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NCT04590274

Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Withdrawn Phase 1 Last updated 5 December 2021
What this trial tests

Phase 1 trial testing Hydroxychloroquine in Covid19. Withdrawn.

Timeline
1 November 2020
Primary endpoint
1 December 2021
1 December 2021

Quick facts

Lead sponsorInternational Brain Research Foundation
PhasePhase 1
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Start date1 November 2020
Primary completion1 December 2021
Estimated completion1 December 2021

Drugs / interventions tested

Conditions studied

Sponsor

International Brain Research Foundation

Who can join

Eligibility, any sex, with Covid19 or SARS (Severe Acute Respiratory Syndrome). Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Coronavirus Disease 2019 (COVID-19) (previously called 2019-nCOV acute respiratory disease) is caused by SARS-CoV-2, a positive-sense single-stranded RNA virus of the coronavirus family. The coronaviruses are largely responsible for the common cold, the 2002 SARS outbreak in Guangdong, China, the 2012 MERS outbreak in Saudi Arabia, and the present COVID-19 outbreak that originated in Wuhan, China. Much has been reported by way of systemic injury caused by COVID-19 affecting the cardiovascular, hepatic, nervous systems. These conditions are likely the result of the virus overwhelming the immune system. For these reasons, the investigators wish to conduct this study using existing medications off-label, and over-the-counter supplements to support the immune response, prevent lasting injury, and hasten the recovery from COVID-19.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Thyroid and COVID-19: a review on pathophysiological, clinical and organizational aspects.
    Lisco G, De Tullio A, Jirillo E, Giagulli VA, et al · · 2021 · cited 62× · PMID 33765288 · DOI 10.1007/s40618-021-01554-z
  2. The Therapeutic and Prophylactic Potential of Quercetin against COVID-19: An Outlook on the Clinical Studies, Inventive Compositions, and Patent Literature.
    Imran M, Thabet HK, Alaqel SI, Alzahrani AR, et al · · 2022 · cited 45× · PMID 35624740 · DOI 10.3390/antiox11050876
  3. TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.
    Kaushik D, Bhandari R, Kuhad A. · · 2021 · cited 45× · PMID 33857397 · DOI 10.1080/14728222.2021.1918103
  4. Potential molecular mechanisms of zinc- and copper-mediated antiviral activity on COVID-19.
    Rani I, Goyal A, Bhatnagar M, Manhas S, et al · · 2021 · cited 43× · PMID 34284268 · DOI 10.1016/j.nutres.2021.05.008
  5. Molecular Mechanisms of Possible Action of Phenolic Compounds in COVID-19 Protection and Prevention.
    Gligorijevic N, Radomirovic M, Nedic O, Stojadinovic M, et al · · 2021 · cited 14× · PMID 34830267 · DOI 10.3390/ijms222212385
  6. Development of Therapeutic and Prophylactic Zinc Compositions for Use against COVID-19: A Glimpse of the Trends, Inventions, and Patents.
    Imran M, Fatima W, Alzahrani AK, Suhail N, et al · · 2022 · cited 13× · PMID 35334884 · DOI 10.3390/nu14061227
  7. A critical evaluation of risk to reward ratio of quercetin supplementation for COVID-19 and associated comorbid conditions.
    Pawar A, Russo M, Rani I, Rani I, et al · · 2022 · cited 12× · PMID 35393674 · DOI 10.1002/ptr.7461
  8. Recent Updates in Experimental Research and Clinical Evaluation on Drugs for COVID-19 Treatment.
    Zou H, Yang Y, Dai H, Xiong Y, et al · · 2021 · cited 12× · PMID 34880750 · DOI 10.3389/fphar.2021.732403

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