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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)
Phase 1 trial testing Hydroxychloroquine in Covid19. Withdrawn.
1 December 2021
Quick facts
| Lead sponsor | International Brain Research Foundation |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Start date | 1 November 2020 |
| Primary completion | 1 December 2021 |
| Estimated completion | 1 December 2021 |
Drugs / interventions tested
- Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →
- Vitamins and Minerals
- Azithromycin (azithromycin) — full drug profile →
Conditions studied
- Covid19 — all drugs for Covid19 →
- SARS (Severe Acute Respiratory Syndrome) — all drugs for SARS (Severe Acute Respiratory Syndrome) →
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.
-
Percentage of individuals who develop COVID-19 symptoms
Time frame: 6 months from study start
The investigators will compare what percentage of participants in this study go on to develop COVID-19 symptoms, as compared to individuals not on the medicational regimen in this study.
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT04590274
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04590274 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by International Brain Research Foundation
- Last refreshed: 5 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04590274.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing