Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
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ClinicalTrials.gov Identifier: NCT04349592 |
Recruitment Status :
Completed
First Posted : April 16, 2020
Last Update Posted : February 23, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Drug: Hydroxychloroquine Drug: Azithromycin Other: Placebo Tablet Other: Placebo capsules | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 456 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double-blinded trial |
Primary Purpose: | Treatment |
Official Title: | Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19 |
Actual Study Start Date : | April 14, 2020 |
Actual Primary Completion Date : | August 14, 2020 |
Actual Study Completion Date : | August 30, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Combination therapy group
hydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5
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Drug: Hydroxychloroquine
Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
Other Name: Plaquenil, Drug: Azithromycin Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
Other Name: Zithromax, Azithrocin |
Active Comparator: Monotherapy therapy group
hydroxychloroquine 200mg TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
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Drug: Hydroxychloroquine
Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
Other Name: Plaquenil, Other: Placebo capsules Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5. |
Placebo Comparator: Control group
Placebo Cap TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
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Other: Placebo Tablet
Oral, one tablet three times a day for 7 days Other: Placebo capsules Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5. |
- Proportion of virologically cured (PCR-negative status) as assessed on day six [ Time Frame: Day 6 ]Days
- virologic cure on other study days [ Time Frame: Day14 and Day 21 ]Days
- virologic semiquantitative analysis of changing viral load [ Time Frame: Day 1 to Day 21 ]Days
- proportion of initially symtomatic subjects with disappearance of clinical symptoms [ Time Frame: Day14 and Day 21 ]Days
- proportion of initially asymtomatic subjects with appearance of new clinical symptoms [ Time Frame: Day14 and Day 21 ]Days
- proportions of subjects with potentially medication- related adverse events [ Time Frame: 7 day ]grades

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient is in HMC facility for low-acuity, Covid-positive patients being quarantined.
- Positive Covid test on qualitative assay used during routine care (i.e. not as part of Q-PROTECT)
- Age at least 18
Exclusion Criteria:
- Treating physician judges patient not appropriate for study participation for any reason
- Age <18
- Breastfeeding or pregnancy (patient-reported pregnancy status is sufficient)
- Hypersensitivity to chloroquine or HC or AZ
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History of or known QT prolongation
- EKG required before study entry and on each visit during the subject's first seven days on pro-tocol, during the time period HC is being taken
- Baseline QTc >480 if QRS width normal; QTc >510 if QRS >120
- Known G6PD deficiency, porphyria, or retinopathy (eye exam prior to study entry)
- Known hepatic or renal disease (or abnormality on liver or renal function testing at study day 1)
- Low magnesium or low potassium (by testing on day 1)
- Current (pre-study) therapy with antimalarial or dapsone
- Current (pre-study) therapy with antiviral agents (e.g. oseltamivir)
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Tisdale36 score exceeding 6 as tallied below (based on ACC recommendations)*
- 1 point each: age>67, female sex, or being on loop diuretic
- 2 points each: serum potassium <3.6, QTc>449, acute myocardial infarction
- 3 points each: sepsis, heart failure, QT-prolonging drugs

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349592
Qatar | |
Hamad Medical Corporation | |
Doha, Qatar, 3050 |
Principal Investigator: | Tim R Harris | Hamad Medical Corporation |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Tim Richard Edmund Harris, Professor Tim Richard Edmund Harris, Hamad Medical Corporation |
ClinicalTrials.gov Identifier: | NCT04349592 |
Other Study ID Numbers: |
MRC-05-001 |
First Posted: | April 16, 2020 Key Record Dates |
Last Update Posted: | February 23, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Covid19 Qatar Coronavirus Hydroxychloroquine Respiratory disease |
Pandemic Azithromycin Viral Load Emergency Department SARS-CoV-2 |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases |
Respiratory Tract Diseases Azithromycin Hydroxychloroquine Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |