Clinical trial · Interventional
A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19
Single-center, Phase II, Randomized Double-blind, Placebo-controlled Study of Hydroxychloroquine Compared to Placebo as Treatment for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
NCT04379492CI-TRIAL-00089799withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Emerging evidence does not support the use of HCQ for treatment or prevention of SARS -CoV2 infection. No pts have been enrolled.
Summary
Brief summary (as posted)
This study is being done to see if hydroxychloroquine is an effective treatment for COVID-19.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COVID-19 | — | UNRESOLVED | — |
| COVID19 | — | UNRESOLVED | — |
| Sars-CoV2 | — | UNRESOLVED | — |
| SARS-Cov-2 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydroxychloroquine | Drug | Hydroxychloroquine | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A - hydroxycholoroquine
- description
- Participants will receive hydroxycholoroquine (200-mg tablets) 2 tablets orally q12h for 2 doses on day 1 (load), followed by 1 tablet orally q12h for days 2-5.
- interventionNames
- Drug: Hydroxychloroquine
- type
- PLACEBO_COMPARATOR
- label
- Arm B - placebo
- description
- Participants will receive placebo
- interventionNames
- Other: Placebo
Primary outcomes (2)
- measure
- Clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years and older * Subjects must have a documented positive test for the SARS-CoV-2 infection within 7 days of randomization * Subject must be hospitalized within 72 hours of randomization * Subjects must be receiving standard of care for SARS-CoV-2 * Subject/Legally Authorized Representative (LAR) must have the ability to understand and give informed consent * Subject must be able to take and absorb hydroxychloroquine at the discretion of the investigator Exclusion Criteria: * Prior receipt of hydroxychloroquine for treatment or prophylaxis of SARS-CoV-2 or patient is taking hydroxychloroquine for other approved indications (e.g., lupus, rheumatoid arthritis) * No documented SARS-CoV-2 infection * Mechanical ventilation * Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives Preexisting retinopathy documented in medical history * Pregnancy or Breastfeeding * Concurrent use of any other quinine derivative (chloroquine, mefloquine) or rifamycins (rifampin, rifabutin) * Antiarrhythmic medications (amiodarone, sotalol, dofetilide, procainamide, quinidine, flecainide) * History of glucose-6-phosphate dehydrogenase deficiency * Pre-treatment corrected QT interval (QTc) \>500 milliseconds * Pressor requirement to maintain blood pressure * Alanine aminotransferase (ALT) and/or asparate aminotransferase (AST) level \> 5X upper limit of normal * Creatinine clearance \<30 mL/min or requirement of dialysis or continuous venovenous hemofiltration * Concomitant participation in a therapeutic trial for SARS-CoV-2 or receiving any experimental treatment for SARS-CoV-2 within 7 days of randomization * Any condition that in the opinion of the principal investigator would prevent participation in the trial or would interfere with the trial endpoints
References
Publications (0)
Data not yet available
No reference posted for this study.