Phase 3
Completed N=1,312
Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2
Corona Virus Infection · Acute Respiratory Distress Syndrome · SARS-CoV Infection · Coronavirus
Source: ClinicalTrials.gov NCT04308668 ↗
Enrolled (actual)
1,312
Serious AEs
1.3%
Results posted
May 2021
Primary outcomePrimary: Number of Participants With Active COVID-19 Disease at Day 14 Among Those Who Were Asymptomatic at Baseline — 49; 58 Participants — p=0.35
◆ Published Evidence
Highly cited
1,406citations · ~234 / year
A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19.
Summary
Study Objective:
1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus.
2. To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.
Linked Publications (5)
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A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19.
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Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.
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Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.
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Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19.
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Reply to Neves.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Active COVID-19 Disease at Day 14 Among Those Who Were Asymptomatic at Baseline |
49; 58 | 0.35 |
| PRIMARY Change in Disease Severity Over 14 Days Among Those Who Are Symptomatic at Baseline |
-2.6; -2.33 | 0.117 |
| SECONDARY Rate of Hospitalization |
5; 9 | — |
| SECONDARY Rate of Death |
1; 1 | — |
| SECONDARY Rate of Confirmed SARS-CoV-2 Detection |
11; 9 | — |
| SECONDARY Occurrence of Symptoms Compatible With COVID-19 (Possible Disease) |
48; 55 | — |
| SECONDARY Rate of All-Cause Study Medicine Discontinuation or Withdrawal |
97; 63 | — |
| SECONDARY Overall Symptom Severity at 5 and 14 Days |
-2.22; -2.05; -3.36; -3.08 | — |
| SECONDARY Number of Participants With Severe COVID-19 Disease at 14 Days Among Those Who Are Symptomatic at Trial Entry |
5; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent
- Exposure to a COVID19 case within 4 days as either a household contact or occupational exposure, OR
- Symptomatic COVID19 case with confirmed diagnosis within 4 days of symptom onset OR symptomatic high risk exposure with known COVID19 contact and within 4 days of symptom onset;
Exclusion Criteria
- Current hospitalization
- Allergy to hydroxychloroquine
- Retinal eye disease
- Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
- Known chronic kidney disease, stage 4 or 5 or receiving dialysis
- Structural or ischemic heart disease
- Personal or Family History of Prolonged QT syndrome
- Weight < 50 kg
- Known Porphyria
- Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal, sotalol;
- Current use of medicines which prolong the QT interval including:
- Antimicrobials: levofloxacin, ciprofloxacin, moxifloxacin, azithromycin, clarithromycin, erythromycin, ketoconazole, itraconazole, or mefloquine
- Antidepressants: amitriptyline, citalopram, desipramine, escitalopram, imipramine, doxepin, fluoxetine, wellbutrin, or venlafaxine
- Antipsychotic or mood stabilizers: haloperidol, droperidol, lithium, quetiapine, thioridazine, ziprasidone
- Methadone
- Sumatriptan, zolmitriptan
Data sourced from ClinicalTrials.gov (NCT04308668) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.