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Article ; Online: Remdesivir for 5 or 10 Days in Patients with Severe Covid-19.

Goldman, Jason D / Lye, David C B / Hui, David S / Marks, Kristen M / Bruno, Raffaele / Montejano, Rocio / Spinner, Christoph D / Galli, Massimo / Ahn, Mi-Young / Nahass, Ronald G / Chen, Yao-Shen / SenGupta, Devi / Hyland, Robert H / Osinusi, Anu O / Cao, Huyen / Blair, Christiana / Wei, Xuelian / Gaggar, Anuj / Brainard, Diana M /

Towner, William J / Muñoz, Jose / Mullane, Kathleen M / Marty, Francisco M / Tashima, Karen T / Diaz, George / Subramanian, Aruna

The New England journal of medicine

2020 Volume 383, Issue 19, Page(s) 1827–1837

Abstract: ... Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 ... In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 ... 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned ...

Abstract	Background: Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19). Methods: We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale. Results: In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%). Conclusions: In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.).
MeSH term(s)	Adenosine Monophosphate/administration & dosage ; Adenosine Monophosphate/adverse effects ; Adenosine Monophosphate/analogs & derivatives ; Adult ; Aged ; Alanine/administration & dosage ; Alanine/adverse effects ; Alanine/analogs & derivatives ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Betacoronavirus ; COVID-19 ; Coronavirus Infections/drug therapy ; Coronavirus Infections/mortality ; Coronavirus Infections/therapy ; Drug Administration Schedule ; Female ; Hospitalization ; Humans ; Male ; Middle Aged ; Oxygen Inhalation Therapy ; Pandemics ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/mortality ; Pneumonia, Viral/therapy ; SARS-CoV-2 ; Treatment Outcome ; COVID-19 Drug Treatment
Chemical Substances	Antiviral Agents ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Keywords	covid19
Language	English
Publishing date	2020-05-27
Publishing country	United States
Document type	Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2015301
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Article ; Online: Remdesivir for the treatment of COVID-19.

Grundeis, Felicitas / Ansems, Kelly / Dahms, Karolina / Thieme, Volker / Metzendorf, Maria-Inti / Skoetz, Nicole / Benstoem, Carina / Mikolajewska, Agata / Griesel, Mirko / Fichtner, Falk / Stegemann, Miriam

The Cochrane database of systematic reviews

2023 Volume 1, Page(s) CD014962

Abstract: ... CoV-2 infection or mild COVID-19 and hospitalised individuals with moderate to severe COVID-19 ... Effects of remdesivir in hospitalised individuals with moderate to severe COVID-19 With moderate-certainty ... of life. Remdesivir may decrease the rate of serious adverse events at up to 28 days (RR 0.27, 95% CI 0.10 ...

Abstract	Background: Remdesivir is an antiviral medicine approved for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19). This led to widespread implementation, although the available evidence remains inconsistent. This update aims to fill current knowledge gaps by identifying, describing, evaluating, and synthesising all evidence from randomised controlled trials (RCTs) on the effects of remdesivir on clinical outcomes in COVID-19. Objectives: To assess the effects of remdesivir and standard care compared to standard care plus/minus placebo on clinical outcomes in patients treated for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Search methods: We searched the Cochrane COVID-19 Study Register (which comprises the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, ClinicalTrials.gov, World Health Organization (WHO) International Clinical Trials Registry Platform, and medRxiv) as well as Web of Science (Science Citation Index Expanded and Emerging Sources Citation Index) and WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies, without language restrictions. We conducted the searches on 31 May 2022. Selection criteria: We followed standard Cochrane methodology. We included RCTs evaluating remdesivir and standard care for the treatment of SARS-CoV-2 infection compared to standard care plus/minus placebo irrespective of disease severity, gender, ethnicity, or setting. We excluded studies that evaluated remdesivir for the treatment of other coronavirus diseases. Data collection and analysis: We followed standard Cochrane methodology. To assess risk of bias in included studies, we used the Cochrane RoB 2 tool for RCTs. We rated the certainty of evidence using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach for outcomes that were reported according to our prioritised categories: all-cause mortality, in-hospital mortality, clinical improvement (being alive and ready for discharge up to day 28) or worsening (new need for invasive mechanical ventilation or death up to day 28), quality of life, serious adverse events, and adverse events (any grade). We differentiated between non-hospitalised individuals with asymptomatic SARS-CoV-2 infection or mild COVID-19 and hospitalised individuals with moderate to severe COVID-19. Main results: We included nine RCTs with 11,218 participants diagnosed with SARS-CoV-2 infection and a mean age of 53.6 years, of whom 5982 participants were randomised to receive remdesivir. Most participants required low-flow oxygen at baseline. Studies were mainly conducted in high- and upper-middle-income countries. We identified two studies that are awaiting classification and five ongoing studies. Effects of remdesivir in hospitalised individuals with moderate to severe COVID-19 With moderate-certainty evidence, remdesivir probably makes little or no difference to all-cause mortality at up to day 28 (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.81 to 1.06; risk difference (RD) 8 fewer per 1000, 95% CI 21 fewer to 6 more; 4 studies, 7142 participants), day 60 (RR 0.85, 95% CI 0.69 to 1.05; RD 35 fewer per 1000, 95% CI 73 fewer to 12 more; 1 study, 1281 participants), or in-hospital mortality at up to day 150 (RR 0.93, 95% CI 0.84 to 1.03; RD 11 fewer per 1000, 95% CI 25 fewer to 5 more; 1 study, 8275 participants). Remdesivir probably increases the chance of clinical improvement at up to day 28 slightly (RR 1.11, 95% CI 1.06 to 1.17; RD 68 more per 1000, 95% CI 37 more to 105 more; 4 studies, 2514 participants; moderate-certainty evidence). It probably decreases the risk of clinical worsening within 28 days (hazard ratio (HR) 0.67, 95% CI 0.54 to 0.82; RD 135 fewer per 1000, 95% CI 198 fewer to 69 fewer; 2 studies, 1734 participants, moderate-certainty evidence). Remdesivir may make little or no difference to the rate of adverse events of any grade (RR 1.04, 95% CI 0.92 to 1.18; RD 23 more per 1000, 95% CI 46 fewer to 104 more; 4 studies, 2498 participants; low-certainty evidence), or serious adverse events (RR 0.84, 95% CI 0.65 to 1.07; RD 44 fewer per 1000, 95% CI 96 fewer to 19 more; 4 studies, 2498 participants; low-certainty evidence). We considered risk of bias to be low, with some concerns for mortality and clinical course. We had some concerns for safety outcomes because participants who had died did not contribute information. Without adjustment, this leads to an uncertain amount of missing values and the potential for bias due to missing data. Effects of remdesivir in non-hospitalised individuals with mild COVID-19 One of the nine RCTs was conducted in the outpatient setting and included symptomatic people with a risk of progression. No deaths occurred within the 28 days observation period. We are uncertain about clinical improvement due to very low-certainty evidence. Remdesivir probably decreases the risk of clinical worsening (hospitalisation) at up to day 28 (RR 0.28, 95% CI 0.11 to 0.75; RD 46 fewer per 1000, 95% CI 57 fewer to 16 fewer; 562 participants; moderate-certainty evidence). We did not find any data for quality of life. Remdesivir may decrease the rate of serious adverse events at up to 28 days (RR 0.27, 95% CI 0.10 to 0.70; RD 49 fewer per 1000, 95% CI 60 fewer to 20 fewer; 562 participants; low-certainty evidence), but it probably makes little or no difference to the risk of adverse events of any grade (RR 0.91, 95% CI 0.76 to 1.10; RD 42 fewer per 1000, 95% CI 111 fewer to 46 more; 562 participants; moderate-certainty evidence). We considered risk of bias to be low for mortality, clinical improvement, and safety outcomes. We identified a high risk of bias for clinical worsening. Authors' conclusions: Based on the available evidence up to 31 May 2022, remdesivir probably has little or no effect on all-cause mortality or in-hospital mortality of individuals with moderate to severe COVID-19. The hospitalisation rate was reduced with remdesivir in one study including participants with mild to moderate COVID-19. It may be beneficial in the clinical course for both hospitalised and non-hospitalised patients, but certainty remains limited. The applicability of the evidence to current practice may be limited by the recruitment of participants from mostly unvaccinated populations exposed to early variants of the SARS-CoV-2 virus at the time the studies were undertaken. Future studies should provide additional data on the efficacy and safety of remdesivir for defined core outcomes in COVID-19 research, especially for different population subgroups.
MeSH term(s)	Humans ; Middle Aged ; COVID-19 ; SARS-CoV-2 ; COVID-19 Drug Treatment ; Disease Progression ; Randomized Controlled Trials as Topic
Chemical Substances	remdesivir (3QKI37EEHE)
Language	English
Publishing date	2023-01-25
Publishing country	England
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't ; Systematic Review
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.CD014962.pub2
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Article: Remdesivir for 5 or 10 Days in Patients with Severe Covid-19

Towner, William J / Muñoz, Jose / Mullane, Kathleen M / Marty, Francisco M / Tashima, Karen T / Diaz, George / Subramanian, Aruna

N. Engl. j. med

Abstract: ... Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 ... 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days ... In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant ...

Abstract	BACKGROUND: Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19). METHODS: We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale. RESULTS: In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%). CONCLUSIONS: In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.).
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #382019
Database	COVID19

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Book ; Online: Remdesivir for 5 or 10 Days in Patients with Severe Covid-19.

Towner, William J / Muñoz, Jose / Mullane, Kathleen M / Marty, Francisco M / Tashima, Karen T / Diaz, George / Subramanian, Aruna

Articles, Abstracts, and Reports

2020

Abstract	BACKGROUND: Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19). METHODS: We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale. RESULTS: In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%). CONCLUSIONS: In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.).
Keywords	2019-nCoV ; Infectious Disease ; covid19
Subject code	610
Publishing date	2020-05-27T07:00:00Z
Publisher	Providence St. Joseph Health Digital Commons
Publishing country	us
Document type	Book ; Online
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Article ; Online: Remdesivir for 5 or 10 Days in Patients with Severe Covid-19

J.D. Goldman / D.C.B. Lye / D.S. Hui / K.M. Marks / R. Bruno / R. Montejano / C.D. Spinner / M. Galli / M. Ahn / R.G. Nahass / Y. Chen / D. SenGupta / R.H. Hyland / A.O. Osinusi / H. Cao / C. Blair / X. Wei / A. Gaggar / D.M. Brainard /

W.J. Towner / J. Muñoz / K.M. Mullane / F.M. Marty / K.T. Tashima / G. Diaz / A. Subramanian

2020

Abstract	Background Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19). Methods We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale. Results In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P=0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P=0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%). Conclusions In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899. opens in new tab.)
Keywords	Settore MED/17 - Malattie Infettive ; covid19
Language	English
Publisher	Massachusetts Medical Society.
Publishing country	it
Document type	Article ; Online
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Article ; Online: Use of Remdesivir in children with COVID-19: report of an Italian multicenter study.

Romani, Lorenza / Roversi, Marco / Bernardi, Stefania / Venturini, Elisabetta / Garazzino, Silvia / Donà, Daniele / Krzysztofiak, Andrzej / Montagnani, Carlotta / Funiciello, Elisa / Calò Carducci, Francesca Ippolita / Marabotto, Caterina / Castagnola, Elio / Salvini, Filippo / Lancella, Laura / Lo Vecchio, Andrea / Galli, Luisa / Castelli Gattinara, Guido

Italian journal of pediatrics

2024 Volume 50, Issue 1, Page(s) 32

Abstract: ... patients received RDV for 5 days, nine patients up to 10 days. Most children who received RDV longer were ... Therefore, in these cases, we could not establish if it was caused by COVID-19, RDV o both. Patients who received RDV ... of children with COVID-19 treated with RDV between March 2020 and February 2022 in 10 Italian hospitals ...

Abstract	Background: COVID-19 is generally milder in children than in adults, however severe infection has been described in some patients. Few data are available on use of Remdesivir (RDV) in children, as most clinical trials focused on adult patients. We report a multicenter study conducted in 10 Italian Hospitals to investigate the safety of RDV in children affected by COVID-19. Methods: We collected the clinical data of children with COVID-19 treated with RDV between March 2020 and February 2022 in 10 Italian hospitals. Clinical data were compared according to a duration of RDV therapy more or less than 5 days. Linear regression model was used to determine the association of significant variables from the bivariate analysis to the duration of RDV therapy. Results: A total of 50 patients were included, with a median age of 12.8 years. Many patients had at least one comorbidity (78%), mostly obesity. Symptoms were fever (88%), cough (74%) and dyspnea (68%). Most patients were diagnosed with pneumonia of either viral and/or bacterial etiology. Blood test showed leukopenia in 66% and increased C-reactive protein (CRP) levels in 63% of cases. Thirty-six patients received RDV for 5 days, nine patients up to 10 days. Most children who received RDV longer were admitted to the PICU (67%). Treatment with RDV was well tolerated with rare side effects: bradycardia was recorded in 6% of cases, solved in less than 24 h after discontinuation. A mild elevation of transaminases was observed in 26% of cases, however for the 8%, it was still detected before the RDV administration. Therefore, in these cases, we could not establish if it was caused by COVID-19, RDV o both. Patients who received RDV for more than 5 days waited longer for its administration after pneumonia diagnosis. The presence of comorbidities and the duration of O2 administration significantly correlated with the duration of RDV therapy at the linear regression analysis. Conclusion: Our experience indicates that RDV against SARS-CoV-2 is safe and well-tolerated in pediatric populations at high risk of developing severe COVID-19. Our data suggest that delaying RDV therapy after diagnosis of pneumonia may be associated with a longer duration of antiviral therapy, especially in patients with comorbidities.
MeSH term(s)	Child ; Humans ; Adenosine Monophosphate/analogs & derivatives ; Alanine/analogs & derivatives ; Antiviral Agents/therapeutic use ; COVID-19 ; COVID-19 Drug Treatment ; Italy/epidemiology ; SARS-CoV-2
Chemical Substances	Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX) ; Antiviral Agents ; remdesivir (3QKI37EEHE)
Language	English
Publishing date	2024-02-27
Publishing country	England
Document type	Multicenter Study ; Journal Article
ZDB-ID	2088556-8
ISSN	1824-7288 ; 1720-8424
ISSN (online)	1824-7288
ISSN	1720-8424
DOI	10.1186/s13052-024-01606-z
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Article: Study of Efficacy of Injection Remdesivir in Patients of COVID-19.

Chaudhary, Bharat R / Dudhrejia, Prafful J / Gambhir, Rahul M / Rathod, Mahesh M

The Journal of the Association of Physicians of India

2023 Volume 71, Issue 4, Page(s) 11–12

Abstract: ... suspected or laboratory-confirmed COVID-19 patients. Interim analysis of the Solidarity trial revealed no ... to place our data on the efficacy of RDV in patients of COVID-19 with moderate to severe categories ... in hospitalization days was obtained in RDV-treated patients (15 vs 19 days, p-value -0.003). Statistically ...

Abstract	Introduction: The coronavirus disease of 2019 (COVID-19) is a highly contagious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). World Health Organization (WHO) declared it a pandemic on 11th March 2020. Injectable remdesivir (RDV), a repurposed antiviral, was first accorded approval by the United States of America (USA) Food and Drug Administration (FDA) on 1st May 2020, for emergency use to treat suspected or laboratory-confirmed COVID-19 patients. Interim analysis of the Solidarity trial revealed no benefits in patients treated with RDV in any group of patients with COVID-19. Here, we have attempted to place our data on the efficacy of RDV in patients of COVID-19 with moderate to severe categories. Materials and methods: A retrospective review and data analysis of 100 COVID-19 patients with reverse transcriptase polymerase chain reaction (RT-PCR)/rapid antigen test positive was performed. Among them, 50 received RDV in addition to the standard treatment protocol (STP), while the remaining 50 received only the STP. STP is an injectable steroid and heparin, along with other supportive management. Prevalent government guidelines were followed as per usual for the classification of the patients and treatment protocol. Every day of hospitalization, the status of respiratory support was checked, and every 3rd-day inflammatory markers [C-reactive protein (CRP) and D-dimer] were measured until the patient was discharged or died. Statistical analysis of the data was done using online software. Results: Age and comorbidity distribution in both groups ensures adequate matching between the two groups. A statistically significant difference in hospitalization days was obtained in RDV-treated patients (15 vs 19 days, p-value -0.003). Statistically significant differences were not found in mortality (6 vs 10 deaths, p-value -0.27) and reduction in oxygen (O2)/ventilatory support requirements (p-value -0.75) in the RDV group as compared to other groups. The difference in the value of CRP (p-value 0.001) and D-dimer (p-value 0.049) on day 5 is statistically significant in the RDV group as compared to the other groups. Discussion: The finding of a reduction in days of hospitalization was similar to the Adaptive COVID-19 Treatment Trial (ACTT) 1 study conducted by Beigel et al. The mortality data were also comparable to those from WHO's Solidarity trial. No similarity was found in data on the reduction in ordinal scale from higher to lower scale for O2/ventilatory support on day 10 from 0. Similarity regarding the reduction in values of inflammatory markers on day 5 was found in studies conducted by Kannan et al. and Stoeckle et al. Conclusion: We found mortality benefit and reduction in O2 requirements/ventilatory support in RDV plus STP-administered cases as compared to STP only, but statistically, this difference is not significant, which suggests that mortality benefit in the RDV group in our study is merely by chance. Here, we can definitely conclude that days of hospital stay and inflammatory markers are reduced in the RDV plus STP-administered group, and the difference between the two groups is statistically significant, which suggests that early use of RDV could shorten the time to clinical improvement.
MeSH term(s)	Humans ; COVID-19 ; SARS-CoV-2 ; COVID-19 Drug Treatment ; Antiviral Agents/therapeutic use
Chemical Substances	remdesivir (3QKI37EEHE) ; Antiviral Agents
Language	English
Publishing date	2023-07-10
Publishing country	India
Document type	Journal Article
ZDB-ID	800766-4
ISSN	0004-5772
ISSN	0004-5772
DOI	10.5005/japi-11001-0217
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Book ; Online: Statistical review of Remdesivir for 5 or 10 Days in Patients with Severe Covid-19

Hood, Kerry / Wilkinson, Jack

2020

Abstract: ... membership, or any other organisation. Here we review Remdesivir for 5 or 10 Days in Patients with Severe ... an apparently well conducted trial comparing two doses of remdesivir in COVID-19. However, the trial’s value is ... of publications, preprints and protocols from clinical trials of COVID-19 treatments, independent of journal ...

Abstract	The following review has been prepared in collaboration with members of the MRC-NIHR Trials Methodology Research Partnership. The reviewers named above, and other, unnamed discussants of the paper, are all qualified statisticians with experience in clinical trials. Our objective is to provide a rapid review of publications, preprints and protocols from clinical trials of COVID-19 treatments, independent of journal specific review processes. We aim to provide timely, constructive, focused, clear advice aimed at improving both the research outputs under review, as well as future studies. Given our collective expertise (clinical trial statistics) our reviews focus on the designs of the trials and other statistical content (methods, presentation and accuracy of results, inferences). This review reflects the expert opinions of the named authors, and does not imply endorsement by the MRC-NIHR Trials Methodology Research Partnership, its wider membership, or any other organisation. Here we review Remdesivir for 5 or 10 Days in Patients with Severe Covid-19, by Goldman et al . The full text was published on May 27th in The New England Journal of Medicine, and is available at https://www.nejm.org/doi/full/10.1056/NEJMoa2015301. Overall, this was an apparently well conducted trial comparing two doses of remdesivir in COVID-19. However, the trial’s value is diminished by the lack of comparison to the standard-of-care, and its failure to use a non-inferiority to compare the different doses.
Keywords	COVID-19 ; Clinical trial ; RCT ; Remdesivir ; covid19
Subject code	610
Language	English
Publishing date	2020-08-17
Publishing country	eu
Document type	Book ; Online
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Article ; Online: Remdesivir treatment for patients with moderate to severe COVID-19.

Turkish journal of medical sciences

2022 Volume 52, Issue 4, Page(s) 880–887

Abstract: ... and 102 (20.6%) patients had severe COVID-19. The 28-day mortality was 10.1%. The median of the scores ... with increased mortality among patients with moderate/severe COVID-19 receiving remdesivir treatment. ... to evaluate risk factors for mortality and prognosis of adult moderate/severe COVID-19 patients treated ...

Abstract	Background: Remdesivir, which was first developed for the treatment of Ebola disease but failed to meet expectations, has become hope in the fight against the COVID-19 pandemic. This study aimed to evaluate risk factors for mortality and prognosis of adult moderate/severe COVID-19 patients treated with remdesivir, and safety and tolerability of 5 days of remdesivir treatment. Methods: This multicenter prospective observational study was conducted in 14 centers in Turkey. Pregnancy or breastfeeding, multiorgan failure, or usage of vasopressors for septic shock, ALT > 5 × the upper limit of the normal range, or eGRF <30 mL/min or dialysis and receiving favipiravir were the exclusion criteria of the study. Results: Among 500 patients, 494 patients were included in the study. On admission, 392 (79.3%) patients had moderate and 102 (20.6%) patients had severe COVID-19. The 28-day mortality was 10.1%. The median of the scores of the seven-category ordinal scale assessed on days 0, 3, 5, 7 were 4 and 3 on day 14. When the survival status of the patients was evaluated according to the time between the remdesivir start date and the end date of the symptoms, no statistically significant difference was found between the medians of the groups (p = 0.404). In multivariable analysis, age (OR, 1.05; 95%CI, 1.02-1.08; p = 0.003), SpO2 level on admission (OR, 3.03; 95%CI, 1.35-6.81; p = 0.007), heart rate (OR, 2.48; 95%CI, 1.01-6.07; p = 0.047), follow-up site at the hospital (clinic/ICU) (OR, 26.4; 95%CI, 11.6-60.17; p < 0.001) were independently associated with increased mortality. Grade 3 adverse event (AE) was observed in 4 (0.8%) patients. None of the patients experienced grade 4 or 5 AEs. Discussion: Remdesivir is a safe and well-tolerated drug and older age, low SpO2 level on admission, tachycardia, and ICU admission are independently associated with increased mortality among patients with moderate/severe COVID-19 receiving remdesivir treatment.
MeSH term(s)	Adult ; Humans ; Pandemics ; SARS-CoV-2 ; Antiviral Agents/therapeutic use ; Treatment Outcome ; COVID-19 Drug Treatment
Chemical Substances	remdesivir (3QKI37EEHE) ; Antiviral Agents
Language	English
Publishing date	2022-08-10
Publishing country	Turkey
Document type	Observational Study ; Multicenter Study ; Journal Article
ZDB-ID	1183461-4
ISSN	1303-6165 ; 1300-0144
ISSN (online)	1303-6165
ISSN	1300-0144
DOI	10.55730/1300-0144.5387
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Article: Remdesivir Prescription in Pregnant Women Infected with COVID-19: A Report of Compassionate Use.

Zafarbakhsh, Azam / Vaezi, Atefeh / Haghjooy Javanmard, Shaghayegh / Sabet, Fahimeh / Dehghan, Maryam

Advanced biomedical research

2023 Volume 12, Page(s) 163

Abstract: ... continued for 5 or 10 days according to the patient's condition. Maternal and pregnancy outcomes and also ... conducted on 150 pregnant women with moderate to severe COVID-19 infection. Remdesivir was prescribed and ... and efficacy of Remdesivir in pregnant women with COVID-19.: Materials and methods: This study was ...

Abstract	Background: Coronavirus disease 2019 (COVID-19) is an infectious disease that the physiological changes in pregnancy can make pregnant patients more susceptible to more severe forms of this infection. Hence, the treatment of COVID-19 in pregnant women can be challenging. This study was designed to evaluate the safety and efficacy of Remdesivir in pregnant women with COVID-19. Materials and methods: This study was conducted on 150 pregnant women with moderate to severe COVID-19 infection. Remdesivir was prescribed and continued for 5 or 10 days according to the patient's condition. Maternal and pregnancy outcomes and also recovery rates were evaluated. Moreover, additional variables were examined: age, gestational age, symptoms, O2 saturation and laboratory tests at admission, the interval between symptom initiation and admission to hospital and Remdesivir prescription, hospitalization days, and ICU admission. Results: The mean age was 32.37 years. Cough and dyspnea were the most prevalent symptoms (74% and 68.7%, respectively). At the time of admission, 79 (52.7%) women needed low-flow oxygen support, 67 (44.7%) needed high-flow oxygen support, and 4 (2.7%) were intubated. Fifty-four (36%) patients required ICU care. In patients who died (12 women), Remdesivir was prescribed later than those discharged ( Conclusion: The results suggest that the early prescription of Remdesivir in pregnant women with moderate COVID-19 can improve the outcomes.
Language	English
Publishing date	2023-06-30
Publishing country	India
Document type	Journal Article
ZDB-ID	2672524-1
ISSN	2277-9175
ISSN	2277-9175
DOI	10.4103/abr.abr_142_22
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