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Article ; Online: Metformin for Treatment of Acute COVID-19: Systematic Review of Clinical Trial Data Against SARS-CoV-2.

Erickson, Spencer M / Fenno, Sarah L / Barzilai, Nir / Kuchel, George / Bartley, Jenna M / Justice, Jamie Nicole / Buse, John B / Bramante, Carolyn T

Diabetes care

2023 Volume 46, Issue 7, Page(s) 1432–1442

Abstract: Background: Observational and preclinical data suggest metformin may prevent severe coronavirus disease 2019 (COVID-19) outcomes.: Purpose: We conducted a systematic review of randomized, placebo-controlled clinical trials of metformin treatment for ... ...

Abstract	Background: Observational and preclinical data suggest metformin may prevent severe coronavirus disease 2019 (COVID-19) outcomes. Purpose: We conducted a systematic review of randomized, placebo-controlled clinical trials of metformin treatment for COVID-19 to determine whether metformin affects clinical or laboratory outcomes in individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and present a structured summary of preclinical data. Study selection: Two independent reviewers searched PubMed, Scopus, Cochrane COVID-19 Study Register, and ClinicalTrials.gov on 1 February 2023 with no date restrictions for trials where investigators randomized adults with COVID-19 to metformin versus control and assessed clinical and/or laboratory outcomes of interest. The Cochrane Risk of Bias 2 tool was used to assess bias. Data extraction: Two reviewers extracted data pertaining to prespecified outcomes of each interest from each included trial. Data synthesis: The synthesis plan was developed a priori and was guided by Synthesis Without Meta-analysis (SWiM) guidelines. Summary tables and narrative synthesis were used (PROSPERO, 2022, CRD42022349896). Three randomized trials met inclusion criteria. In two of the trials investigators found that metformin improved clinical outcomes (prevented need for oxygen and prevented need for acute health care use), and in the third trial a larger portion of adults with diabetes were enrolled but results did show a direction of benefit similar to that of the other trials in the per-protocol group. In the largest trial, subjects were enrolled during the delta and omicron waves and vaccinated individuals were included. The certainty of evidence that metformin prevents health care use due to COVID-19 was moderate per Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. Many preclinical studies have shown metformin to be effective against SARS-CoV-2. Limitations: Limitations include inclusion of only three trials and heterogeneity between trials. Conclusions: Future trials will help define the role of metformin in COVID-19 treatment guidelines.
MeSH term(s)	Adult ; Humans ; COVID-19 ; SARS-CoV-2 ; Metformin/therapeutic use ; COVID-19 Drug Treatment ; Bias
Chemical Substances	Metformin (9100L32L2N)
Language	English
Publishing date	2023-06-20
Publishing country	United States
Document type	Systematic Review ; Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dc22-2539
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Article: Antibody-mediated cellular responses are dysregulated in Multisystem Inflammatory Syndrome in Children (MIS-C).

Dick, Jenna K / Sangala, Jules A / Krishna, Venkatramana D / Khaimraj, Aaron / Hamel, Lydia / Erickson, Spencer M / Hicks, Dustin / Soigner, Yvette / Covill, Laura E / Johnson, Alexander / Ehrhardt, Michael J / Ernste, Keenan / Brodin, Petter / Koup, Richard A / Khaitan, Alka / Baehr, Carly / Thielen, Beth K / Henzler, Christine M / Skipper, Caleb /

Miller, Jeffrey S / Bryceson, Yenan T / Wu, Jianming / John, Chandy C / Panoskaltsis-Mortari, Angela / Orioles, Alberto / Steiner, Marie E / Cheeran, Maxim C-J / Pravetoni, Marco / Hart, Geoffrey T

bioRxiv : the preprint server for biology

2024

Abstract: Multisystem Inflammatory Syndrome in Children (MIS-C) is a severe complication of SARS-CoV-2 infection characterized by multi-organ involvement and inflammation. Testing of cellular function ex vivo to understand the aberrant immune response in MIS-C is ... ...

Abstract	Multisystem Inflammatory Syndrome in Children (MIS-C) is a severe complication of SARS-CoV-2 infection characterized by multi-organ involvement and inflammation. Testing of cellular function ex vivo to understand the aberrant immune response in MIS-C is limited. Despite strong antibody production in MIS-C, SARS-CoV-2 nucleic acid testing can remain positive for 4-6 weeks after infection. Therefore, we hypothesized that dysfunctional cell-mediated antibody responses downstream of antibody production may be responsible for delayed clearance of viral products in MIS-C. In MIS-C, monocytes were hyperfunctional for phagocytosis and cytokine production, while natural killer (NK) cells were hypofunctional for both killing and cytokine production. The decreased NK cell cytotoxicity correlated with an NK exhaustion marker signature and systemic IL-6 levels. Potentially providing a therapeutic option, cellular engagers of CD16 and SARS-CoV-2 proteins were found to rescue NK cell function in vitro. Together, our results reveal dysregulation in antibody-mediated cellular responses unique to MIS-C that likely contribute to the immune pathology of this disease.
Language	English
Publishing date	2024-04-18
Publishing country	United States
Document type	Preprint
DOI	10.1101/2024.04.16.589585
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Strategies used for the COVID-OUT decentralized trial of outpatient treatment of SARS-CoV-2.

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e242

Abstract: The COVID-19 pandemic accelerated the development of decentralized clinical trials (DCT). DCT's are an important and pragmatic method for assessing health outcomes yet comprise only a minority of clinical trials, and few published methodologies exist. In ...

Abstract	The COVID-19 pandemic accelerated the development of decentralized clinical trials (DCT). DCT's are an important and pragmatic method for assessing health outcomes yet comprise only a minority of clinical trials, and few published methodologies exist. In this report, we detail the operational components of COVID-OUT, a decentralized, multicenter, quadruple-blinded, randomized trial that rapidly delivered study drugs nation-wide. The trial examined three medications (metformin, ivermectin, and fluvoxamine) as outpatient treatment of SARS-CoV-2 for their effectiveness in preventing severe or long COVID-19. Decentralized strategies included HIPAA-compliant electronic screening and consenting, prepacking investigational product to accelerate delivery after randomization, and remotely confirming participant-reported outcomes. Of the 1417 individuals with the intention-to-treat sample, the remote nature of the study caused an additional 94 participants to not take any doses of study drug. Therefore, 1323 participants were in the modified intention-to-treat sample, which was the a priori primary study sample. Only 1.4% of participants were lost to follow-up. Decentralized strategies facilitated the successful completion of the COVID-OUT trial without any in-person contact by expediting intervention delivery, expanding trial access geographically, limiting contagion exposure, and making it easy for participants to complete follow-up visits. Remotely completed consent and follow-up facilitated enrollment.
Language	English
Publishing date	2023-11-07
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.668
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Article ; Online: Outpatient treatment of COVID-19 and incidence of post-COVID-19 condition over 10 months (COVID-OUT): a multicentre, randomised, quadruple-blind, parallel-group, phase 3 trial.

Bramante, Carolyn T / Buse, John B / Liebovitz, David M / Nicklas, Jacinda M / Puskarich, Michael A / Cohen, Ken / Belani, Hrishikesh K / Anderson, Blake J / Huling, Jared D / Tignanelli, Christopher J / Thompson, Jennifer L / Pullen, Matthew / Wirtz, Esteban Lemus / Siegel, Lianne K / Proper, Jennifer L / Odde, David J / Klatt, Nichole R / Sherwood, Nancy E / Lindberg, Sarah M /

Karger, Amy B / Beckman, Kenneth B / Erickson, Spencer M / Fenno, Sarah L / Hartman, Katrina M / Rose, Michael R / Mehta, Tanvi / Patel, Barkha / Griffiths, Gwendolyn / Bhat, Neeta S / Murray, Thomas A / Boulware, David R

The Lancet. Infectious diseases

2023 Volume 23, Issue 10, Page(s) 1119–1129

Abstract: Background: Post-COVID-19 condition (also known as long COVID) is an emerging chronic illness potentially affecting millions of people. We aimed to evaluate whether outpatient COVID-19 treatment with metformin, ivermectin, or fluvoxamine soon after SARS- ...

Abstract	Background: Post-COVID-19 condition (also known as long COVID) is an emerging chronic illness potentially affecting millions of people. We aimed to evaluate whether outpatient COVID-19 treatment with metformin, ivermectin, or fluvoxamine soon after SARS-CoV-2 infection could reduce the risk of long COVID. Methods: We conducted a decentralised, randomised, quadruple-blind, parallel-group, phase 3 trial (COVID-OUT) at six sites in the USA. We included adults aged 30-85 years with overweight or obesity who had COVID-19 symptoms for fewer than 7 days and a documented SARS-CoV-2 positive PCR or antigen test within 3 days before enrolment. Participants were randomly assigned via 2 × 3 parallel factorial randomisation (1:1:1:1:1:1) to receive metformin plus ivermectin, metformin plus fluvoxamine, metformin plus placebo, ivermectin plus placebo, fluvoxamine plus placebo, or placebo plus placebo. Participants, investigators, care providers, and outcomes assessors were masked to study group assignment. The primary outcome was severe COVID-19 by day 14, and those data have been published previously. Because the trial was delivered remotely nationwide, the a priori primary sample was a modified intention-to-treat sample, meaning that participants who did not receive any dose of study treatment were excluded. Long COVID diagnosis by a medical provider was a prespecified, long-term secondary outcome. This trial is complete and is registered with ClinicalTrials.gov, NCT04510194. Findings: Between Dec 30, 2020, and Jan 28, 2022, 6602 people were assessed for eligibility and 1431 were enrolled and randomly assigned. Of 1323 participants who received a dose of study treatment and were included in the modified intention-to-treat population, 1126 consented for long-term follow-up and completed at least one survey after the assessment for long COVID at day 180 (564 received metformin and 562 received matched placebo; a subset of participants in the metformin vs placebo trial were also randomly assigned to receive ivermectin or fluvoxamine). 1074 (95%) of 1126 participants completed at least 9 months of follow-up. 632 (56·1%) of 1126 participants were female and 494 (43·9%) were male; 44 (7·0%) of 632 women were pregnant. The median age was 45 years (IQR 37-54) and median BMI was 29·8 kg/m Interpretation: Outpatient treatment with metformin reduced long COVID incidence by about 41%, with an absolute reduction of 4·1%, compared with placebo. Metformin has clinical benefits when used as outpatient treatment for COVID-19 and is globally available, low-cost, and safe. Funding: Parsemus Foundation; Rainwater Charitable Foundation; Fast Grants; UnitedHealth Group Foundation; National Institute of Diabetes, Digestive and Kidney Diseases; National Institutes of Health; and National Center for Advancing Translational Sciences.
MeSH term(s)	Adult ; Pregnancy ; Humans ; Male ; Female ; Middle Aged ; COVID-19 ; Incidence ; Ivermectin/therapeutic use ; Post-Acute COVID-19 Syndrome ; COVID-19 Drug Treatment ; Fluvoxamine ; Outpatients ; SARS-CoV-2 ; Metformin/therapeutic use ; Double-Blind Method ; Treatment Outcome
Chemical Substances	Ivermectin (70288-86-7) ; Fluvoxamine (O4L1XPO44W) ; Metformin (9100L32L2N)
Language	English
Publishing date	2023-06-08
Publishing country	United States
Document type	Randomized Controlled Trial ; Multicenter Study ; Clinical Trial, Phase III ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(23)00299-2
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Article ; Online: Favorable Antiviral Effect of Metformin on Severe Acute Respiratory Syndrome Coronavirus 2 Viral Load in a Randomized, Placebo-Controlled Clinical Trial of Coronavirus Disease 2019.

Bramante, Carolyn T / Beckman, Kenneth B / Mehta, Tanvi / Karger, Amy B / Odde, David J / Tignanelli, Christopher J / Buse, John B / Johnson, Darrell M / Watson, Ray H B / Daniel, Jerry J / Liebovitz, David M / Nicklas, Jacinda M / Cohen, Ken / Puskarich, Michael A / Belani, Hrishikesh K / Siegel, Lianne K / Klatt, Nichole R / Anderson, Blake / Hartman, Katrina M /

Rao, Via / Hagen, Aubrey A / Patel, Barkha / Fenno, Sarah L / Avula, Nandini / Reddy, Neha V / Erickson, Spencer M / Fricton, Regina D / Lee, Samuel / Griffiths, Gwendolyn / Pullen, Matthew F / Thompson, Jennifer L / Sherwood, Nancy E / Murray, Thomas A / Rose, Michael R / Boulware, David R / Huling, Jared D

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2024

Abstract: Background: Metformin has antiviral activity against RNA viruses including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The mechanism appears to be suppression of protein translation via targeting the host mechanistic target of ... ...

Abstract	Background: Metformin has antiviral activity against RNA viruses including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The mechanism appears to be suppression of protein translation via targeting the host mechanistic target of rapamycin pathway. In the COVID-OUT randomized trial for outpatient coronavirus disease 2019 (COVID-19), metformin reduced the odds of hospitalizations/death through 28 days by 58%, of emergency department visits/hospitalizations/death through 14 days by 42%, and of long COVID through 10 months by 42%. Methods: COVID-OUT was a 2 × 3 randomized, placebo-controlled, double-blind trial that assessed metformin, fluvoxamine, and ivermectin; 999 participants self-collected anterior nasal swabs on day 1 (n = 945), day 5 (n = 871), and day 10 (n = 775). Viral load was quantified using reverse-transcription quantitative polymerase chain reaction. Results: The mean SARS-CoV-2 viral load was reduced 3.6-fold with metformin relative to placebo (-0.56 log10 copies/mL; 95% confidence interval [CI], -1.05 to -.06; P = .027). Those who received metformin were less likely to have a detectable viral load than placebo at day 5 or day 10 (odds ratio [OR], 0.72; 95% CI, .55 to .94). Viral rebound, defined as a higher viral load at day 10 than day 5, was less frequent with metformin (3.28%) than placebo (5.95%; OR, 0.68; 95% CI, .36 to 1.29). The metformin effect was consistent across subgroups and increased over time. Neither ivermectin nor fluvoxamine showed effect over placebo. Conclusions: In this randomized, placebo-controlled trial of outpatient treatment of SARS-CoV-2, metformin significantly reduced SARS-CoV-2 viral load, which may explain the clinical benefits in this trial. Metformin is pleiotropic with other actions that are relevant to COVID-19 pathophysiology. Clinical trials registration: NCT04510194.
Language	English
Publishing date	2024-05-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciae159
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Article ; Online: Antibody-mediated cellular responses are dysregulated in Multisystem Inflammatory Syndrome in Children (MIS-C)

Dick, Jenna K / Sangala, Jules A / Krishna, Venkatramana D / Khaimraj, Aaron / Hamel, Lydia / Erickson, Spencer M / Hicks, Dustin / Soigner, Yvette / Covill, Laura E / Johnson, Alexander / Ehrhardt, Michael J / Ernst, Keenan / Brodin, Petter / Koup, Richard A / Khaitan, Alka / Baehr, Carly / Thielen, Beth K / Henzler, Christine M / Skipper, Caleb /

Miller, Jeffrey S / Bryceson, Yenan T / Wu, Jianming / John, Chandy C / Panoskaltsis-Mortari, Angela / Orioles, Alberto / Steiner, Marie E / Cheeran, Maxim C-J / Pravetoni, Marco / Hart, Geoffrey T

bioRxiv

Abstract	Multisystem Inflammatory Syndrome in Children (MIS-C) is a severe complication of SARS-CoV-2 infection characterized by multi-organ involvement and inflammation. Testing of cellular function ex vivo to understand the aberrant immune response in MIS-C is limited. Despite strong antibody production in MIS-C, SARS-CoV-2 nucleic acid testing can remain positive for 4-6 weeks after infection. Therefore, we hypothesized that dysfunctional cell-mediated antibody responses downstream of antibody production may be responsible for delayed clearance of viral products in MIS-C. In MIS-C, monocytes were hyperfunctional for phagocytosis and cytokine production, while natural killer (NK) cells were hypofunctional for both killing and cytokine production. The decreased NK cell cytotoxicity correlated with an NK exhaustion marker signature and systemic IL-6 levels. Potentially providing a therapeutic option, cellular engagers of CD16 and SARS-CoV-2 proteins were found to rescue NK cell function in vitro. Together, our results reveal dysregulation in antibody-mediated cellular responses unique to MIS-C that likely contribute to the immune pathology of this disease.
Keywords	covid19
Language	English
Publishing date	2024-04-18
Publisher	Cold Spring Harbor Laboratory
Document type	Article ; Online
DOI	10.1101/2024.04.16.589585
Database	COVID19

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Article ; Online: Antibody-mediated cellular responses are dysregulated in Multisystem Inflammatory Syndrome in Children (MIS-C)

Miller, Jeffrey S / Bryceson, Yenan T / Wu, Jianming / John, Chandy C / Panoskaltsis-Mortari, Angela / Orioles, Alberto / Steiner, Marie E / Cheeran, Maxim C-J / Pravetoni, Marco / Hart, Geoffrey T

bioRxiv

Abstract	Multisystem Inflammatory Syndrome in Children (MIS-C) is a severe complication of SARS-CoV-2 infection characterized by multi-organ involvement and inflammation. Testing of cellular function ex vivo to understand the aberrant immune response in MIS-C is limited. Despite strong antibody production in MIS-C, SARS-CoV-2 nucleic acid testing can remain positive for 4-6 weeks after infection. Therefore, we hypothesized that dysfunctional cell-mediated antibody responses downstream of antibody production may be responsible for delayed clearance of viral products in MIS-C. In MIS-C, monocytes were hyperfunctional for phagocytosis and cytokine production, while natural killer (NK) cells were hypofunctional for both killing and cytokine production. The decreased NK cell cytotoxicity correlated with an NK exhaustion marker signature and systemic IL-6 levels. Potentially providing a therapeutic option, cellular engagers of CD16 and SARS-CoV-2 proteins were found to rescue NK cell function in vitro. Together, our results reveal dysregulation in antibody-mediated cellular responses unique to MIS-C that likely contribute to the immune pathology of this disease.
Keywords	covid19
Language	English
Publishing date	2024-04-18
Publisher	Cold Spring Harbor Laboratory
Document type	Article ; Online
DOI	10.1101/2024.04.16.589585
Database	COVID19

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Article ; Online: Impact of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination and Booster on Coronavirus Disease 2019 (COVID-19) Symptom Severity Over Time in the COVID-OUT Trial.

Boulware, David R / Murray, Thomas A / Proper, Jennifer L / Tignanelli, Christopher J / Buse, John B / Liebovitz, David M / Nicklas, Jacinda M / Cohen, Kenneth / Puskarich, Michael A / Belani, Hrishikesh K / Siegel, Lianne K / Klatt, Nichole R / Odde, David J / Karger, Amy B / Ingraham, Nicholas E / Hartman, Katrina M / Rao, Via / Hagen, Aubrey A / Patel, Barkha /

Fenno, Sarah L / Avula, Nandini / Reddy, Neha V / Erickson, Spencer M / Lindberg, Sarah / Fricton, Regina / Lee, Samuel / Zaman, Adnin / Saveraid, Hanna G / Tordsen, Walker J / Pullen, Matthew F / Sherwood, Nancy E / Huling, Jared D / Bramante, Carolyn T

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2022 Volume 76, Issue 3, Page(s) e1–e9

Abstract: Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination has decreasing protection from acquiring any infection with emergence of new variants; however, vaccination continues to protect against progression to severe ... ...

Abstract	Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination has decreasing protection from acquiring any infection with emergence of new variants; however, vaccination continues to protect against progression to severe coronavirus disease 2019 (COVID-19). The impact of vaccination status on symptoms over time is less clear. Methods: Within a randomized trial on early outpatient COVID-19 therapy testing metformin, ivermectin, and/or fluvoxamine, participants recorded symptoms daily for 14 days. Participants were given a paper symptom diary allowing them to circle the severity of 14 symptoms as none (0), mild (1), moderate (2), or severe (3). This is a secondary analysis of clinical trial data on symptom severity over time using generalized estimating equations comparing those unvaccinated, SARS-CoV-2 vaccinated with primary vaccine series only, or vaccine-boosted. Results: The parent clinical trial prospectively enrolled 1323 participants, of whom 1062 (80%) prospectively recorded some daily symptom data. Of these, 480 (45%) were unvaccinated, 530 (50%) were vaccinated with primary series only, and 52 (5%) vaccine-boosted. Overall symptom severity was least for the vaccine-boosted group and most severe for unvaccinated at baseline and over the 14 days (P < .001). Individual symptoms were least severe in the vaccine-boosted group including cough, chills, fever, nausea, fatigue, myalgia, headache, and diarrhea, as well as smell and taste abnormalities. Results were consistent over Delta and Omicron variant time periods. Conclusions: SARS-CoV-2 vaccine-boosted participants had the least severe symptoms during COVID-19, which abated the quickest over time. Clinical Trial Registration. NCT04510194.
MeSH term(s)	Humans ; COVID-19/prevention & control ; COVID-19 Vaccines ; SARS-CoV-2 ; Vaccination
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2022-09-16
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciac772
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Article: Metformin reduces SARS-CoV-2 in a Phase 3 Randomized Placebo Controlled Clinical Trial.

Bramante, Carolyn T / Beckman, Kenneth B / Mehta, Tanvi / Karger, Amy B / Odde, David J / Tignanelli, Christopher J / Buse, John B / Johnson, Darrell M / Watson, Ray H B / Daniel, Jerry J / Liebovitz, David M / Nicklas, Jacinda M / Cohen, Kenneth / Puskarich, Michael A / Belani, Hrishikesh K / Siegel, Lianne K / Klatt, Nichole R / Anderson, Blake / Hartman, Katrina M /

Rao, Via / Hagen, Aubrey A / Patel, Barkha / Fenno, Sarah L / Avula, Nandini / Reddy, Neha V / Erickson, Spencer M / Fricton, Regina D / Lee, Samuel / Griffiths, Gwendolyn / Pullen, Matthew F / Thompson, Jennifer L / Sherwood, Nancy / Murray, Thomas A / Rose, Michael R / Boulware, David R / Huling, Jared D

medRxiv : the preprint server for health sciences

2023

Abstract: Current antiviral treatment options for SARS-CoV-2 infections are not available globally, cannot be used with many medications, and are limited to virus-specific targets. ...

Abstract	Current antiviral treatment options for SARS-CoV-2 infections are not available globally, cannot be used with many medications, and are limited to virus-specific targets.
Language	English
Publishing date	2023-06-07
Publishing country	United States
Document type	Preprint
DOI	10.1101/2023.06.06.23290989
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Article ; Online: Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19.

Bramante, Carolyn T / Huling, Jared D / Tignanelli, Christopher J / Buse, John B / Liebovitz, David M / Nicklas, Jacinda M / Cohen, Kenneth / Puskarich, Michael A / Belani, Hrishikesh K / Proper, Jennifer L / Siegel, Lianne K / Klatt, Nichole R / Odde, David J / Luke, Darlette G / Anderson, Blake / Karger, Amy B / Ingraham, Nicholas E / Hartman, Katrina M / Rao, Via /

Hagen, Aubrey A / Patel, Barkha / Fenno, Sarah L / Avula, Nandini / Reddy, Neha V / Erickson, Spencer M / Lindberg, Sarah / Fricton, Regina / Lee, Samuel / Zaman, Adnin / Saveraid, Hanna G / Tordsen, Walker J / Pullen, Matthew F / Biros, Michelle / Sherwood, Nancy E / Thompson, Jennifer L / Boulware, David R / Murray, Thomas A

The New England journal of medicine

2022 Volume 387, Issue 7, Page(s) 599–610

Abstract: Background: Early treatment to prevent severe coronavirus disease 2019 (Covid-19) is an important component of the comprehensive response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic.: Methods: In this phase 3, double- ... ...

Abstract	Background: Early treatment to prevent severe coronavirus disease 2019 (Covid-19) is an important component of the comprehensive response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Methods: In this phase 3, double-blind, randomized, placebo-controlled trial, we used a 2-by-3 factorial design to test the effectiveness of three repurposed drugs - metformin, ivermectin, and fluvoxamine - in preventing serious SARS-CoV-2 infection in nonhospitalized adults who had been enrolled within 3 days after a confirmed diagnosis of infection and less than 7 days after the onset of symptoms. The patients were between the ages of 30 and 85 years, and all had either overweight or obesity. The primary composite end point was hypoxemia (≤93% oxygen saturation on home oximetry), emergency department visit, hospitalization, or death. All analyses used controls who had undergone concurrent randomization and were adjusted for SARS-CoV-2 vaccination and receipt of other trial medications. Results: A total of 1431 patients underwent randomization; of these patients, 1323 were included in the primary analysis. The median age of the patients was 46 years; 56% were female (6% of whom were pregnant), and 52% had been vaccinated. The adjusted odds ratio for a primary event was 0.84 (95% confidence interval [CI], 0.66 to 1.09; P = 0.19) with metformin, 1.05 (95% CI, 0.76 to 1.45; P = 0.78) with ivermectin, and 0.94 (95% CI, 0.66 to 1.36; P = 0.75) with fluvoxamine. In prespecified secondary analyses, the adjusted odds ratio for emergency department visit, hospitalization, or death was 0.58 (95% CI, 0.35 to 0.94) with metformin, 1.39 (95% CI, 0.72 to 2.69) with ivermectin, and 1.17 (95% CI, 0.57 to 2.40) with fluvoxamine. The adjusted odds ratio for hospitalization or death was 0.47 (95% CI, 0.20 to 1.11) with metformin, 0.73 (95% CI, 0.19 to 2.77) with ivermectin, and 1.11 (95% CI, 0.33 to 3.76) with fluvoxamine. Conclusions: None of the three medications that were evaluated prevented the occurrence of hypoxemia, an emergency department visit, hospitalization, or death associated with Covid-19. (Funded by the Parsemus Foundation and others; COVID-OUT ClinicalTrials.gov number, NCT04510194.).
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; COVID-19/complications ; COVID-19 Vaccines ; Double-Blind Method ; Female ; Fluvoxamine/therapeutic use ; Humans ; Hypoxia/etiology ; Ivermectin/therapeutic use ; Male ; Metformin/therapeutic use ; Middle Aged ; Obesity/complications ; Overweight/complications ; Pregnancy ; Pregnancy Complications, Infectious/drug therapy ; SARS-CoV-2 ; COVID-19 Drug Treatment
Chemical Substances	COVID-19 Vaccines ; Ivermectin (70288-86-7) ; Metformin (9100L32L2N) ; Fluvoxamine (O4L1XPO44W)
Language	English
Publishing date	2022-09-08
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; 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/NEJMoa2201662
Database	MEDical Literature Analysis and Retrieval System OnLINE

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