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COVID-19 Clinical Trials

| Go to VA Research on COVID-19 |

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 CT, Beckman KB, Mehta T, Karger AB, Odde DJ, Tignanelli CJ, Buse JB et al. Metformin reduced SARS-CoV-2 viral load 3.6-fold compared to placebo. Clin Infect Dis. 2024 May 1. Online ahead of print.

High-dose fluvoxamine and time to sustained recovery in outpatients with COVID-19: The ACTIV-6 randomized clinical trial . Stewart TG, Rebolledo PA, Mourad A, Lindsell CJ, Boulware DR, McCarthy MW et al. Among outpatients with mild to moderate COVID-19, treatment with fluvoxamine does not reduce duration of COVID-19 symptoms. JAMA. 2023 Nov 17. Online ahead of print.

Core warming of coronavirus disease 2019 patients undergoing mechanical ventilation: A pilot study . Bonfanti NP, Mohr NM, Willms DC, Bedimo RJ, Gundert E, Goff KL, Kulstad EB, Brewry AM. This pilot study suggests that core warming of patients with COVID-19 undergoing mechanical ventilation is feasible and appears safe. Inducing fever has potential to improve respiratory physiology in patients with COVID-19. Ther Hypothermia Temp Manag. 2023 Aug 2. Online ahead of print.

Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): A randomised, placebo-controlled trial . Brown SM, Barkauska CE, Grund B, Sharma S, Phillips AN, Leither L, Peltran ID et al. Among patients with COVID-19-associated acute hypoxaemic respiratory failure, aviptadil did not significantly improve clinical outcomes up to day 90 when compared with placebo. Lancet Respir Med. 2023 Jun 19. Online ahead of print.

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 CT, Buse JB, Liebovits DM, Nicklas JM, Puskarich MA, Cohen K, Belani HK, Anderson BJ et al. Outpatient treatment with metformin reduced long COVID incidence by about 41% compared with placebo. Lancet Infect Dis. 2023 Jun 8. Online ahead of print.

The effect of povidone-iodine nasal spray on nasopharyngeal SARS-Co-V-2 viral load: A randomized control trial. Zarabanda D, Vukkadala N, Phillips KM, Qian ZJ, Mfuh KO, Hatter JN, Lee IT et al. Dilute versions of povidone-iodine nasal spray are safe for topical use in the nasal cavity, but the spray does not demonstrate virus-eliminating activity in COVID-19 positive patients. Laryngoscope. 2022 Nov;132(11):2089-2095.

Efficacy and safety of ensovibep for adults hospitalized with COVID-19: A randomized controlled trial. ACTIV-3/TICO Study Group et al. Compared with placebo, the medication ensovibep did not improve clinical outcomes for hospitalized participants with COVID-19 standard care, including remdesivir. No safety concerns were identified. Ann Intern Med. 2022 Sep;175(9):1266-1274.

A pilot randomized controlled trial of supervised, at-home, self-administered transcutaneous auricular vagus nerve stimulation (taVNS) to manage long COVID symptoms. Badran BW, Huffman SM, Dancy M, Austelle CW, Bikson M, Kautz SA, George MS. Supervised, self-administered stimulation of the vagus nerve to relieve mental fatigue symptoms related to long COVID is safe and feasible. Larger studies can safely investigate the effectiveness of this treatment. Bioelectron Med. 2022 Aug 25;8(1):13.

Randomized trial on metformin, ivermectin, and fluvoxamine for Covid-19. Bramante CT, Huling JD, Tignanelli CJ, Buse JB, Liebovitz DM, Nicklas JM, Cohen K et al. Metformin, ivermectin, and fluvoxamine did not prevent low blood oxygen, emergency department visits, hospitalizations, or death associated with COVID-19. N Engl J Med. 2022 Aug 18;387(7):599-610.

Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomized, double-blind placebo-controlled trial. Wolfe CR, Tomashek KM, Patterson TF, Gomez CA, Marconi VA, Jain MK, Yang OO et al. In hospitalized patients with COVID-19 requiring supplemental oxygen, baricitinib plus remdesivir and dexamethasone plus remdesivir resulted in similar mechanical ventilation-free survival by day 29, but dexamethasone was associated with significantly more adverse events. Lancet Respir Med. 2022 May 23. Online ahead of print.

A multicenter evaluation of the Seraph 100 microbind affinity blood filter for the treatment of severe COVID-19. Chitty SA, Mobbs S, Rifkin BS, Stogner SW, Lewis MS, Betancort J, DellaVolpe J et al. Findings suggest that broad spectrum, pathogen agnostic blood purification can be safely deployed to meet new pathogen threats while awaiting targeted therapies and vaccines. Crit Care Explor. 2022 Mar 25;4(4):e0662.

Efficacy and safety of baricitinib plus standard care for the treatment of critically ill hospitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: An exploratory, randomised placebo-controlled trial. Ely EW, Ramanan AV, Kartman CE, de Bono S, Liao R, Piruzeli MLB, Goldman JD et al. In a small exploratory study of critically ill, hospitalized COVID-19 patients on ventilation or extracorporeal membrane oxygenation, treatment with baricitinib reduced mortality. Lancet Respir Med. 2022 Feb 3. Online ahead of print.

The effect of povidone-iodine nasal spray on COVID-19 nasopharyngeal viral load in patients: A randomized control trial. Zarabanda D, Vukkadala N, Phillips KM, Qian ZJ, Mfuh KO, Hatter M, Lee IT et al. Data suggest that dilute version of povidone-iodine nasal spray are safe for topical use in the nasal cavity, but that the spray does not demonstrate virucidal activity in COVID-19 positive outpatients. Laryngoscope. 2021 Nov 1. Online ahead of print.

Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): A randomised, double-blind, parallel-group, placebo-controlled phase 3 trial. Marconi VC, Ramanan AV, de Bono S, Kartman CE, Krishnan V, Liao R, Piruzeli ML et al. Although there was no significant reduction in the frequency of disease progression overall, treatment with baricitinib in addition to standard of care (including dexamethasone) had a similar safety profile to that of standard care alone, and was associated with reduced mortality in hospitalized adults with COVID-19. Lancet Respir Med. 2021 Aug 31. Online ahead of print.

Baricitinib plus remdesivir for hospitalized adults with Covid-19. Kalil AC, et al. Baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with COVID-19, notably among those receiving high-flow oxygen or noninvasive ventilation. N Eng J Med. 2021 Mar 4;384(9):795-807.

A neutralizing monoclonal antibody for hospitalized patients with Covid-19. ACTIV-3/TICO LY-CoV555 Study group, Lundgren JD, et al. Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had COVID-19. N Engl J Med. 2020 Dec 22. Online ahead of print.

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