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Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.
Reducing viral load is potentially key to reducing viral transmission between humans. Observational data suggests HC and AZ may reduce the viral load. In this study we will randomise ambulatory patients with Covid 19 (confirmed by PCR in combination with clinical symptoms) to receive HC/AZ or HC/placebo or placebo for 7 days. On days 2-14, participants will be reviewed by a member of the research team and samples will be obtained for viral load, an ECG recorded and physical examination performed. On days 15-20, participants will be reviewed by telephone using a semi structured questionnaire. On day 21 participants will be examined in person and an oronasopharyngeal swabs obtained for PCR analysis. Participants will be followed for 6 months via their medical records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination therapy group | Experimental | hydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5 |
|
| Monotherapy therapy group | Active Comparator | hydroxychloroquine 200mg TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5 |
|
| Control group | Placebo Comparator | Placebo Cap TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of virologically cured (PCR-negative status) as assessed on day six | Days | Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| virologic cure on other study days | Days | Day14 and Day 21 |
| virologic semiquantitative analysis of changing viral load | Days | Day 1 to Day 21 |
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Inclusion Criteria:
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
History of or known QT prolongation
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)
Tisdale36 score exceeding 6 as tallied below (based on ACC recommendations)*
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| Name | Affiliation | Role |
|---|---|---|
| Tim R Harris | Hamad Medical Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Corporation | Doha | 3050 | Qatar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31978945 | Background | Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. | |
| 32007143 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D012120 | Respiration Disorders |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Double-blinded trial
|
| Azithromycin | Drug | Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5. |
|
|
| Placebo Tablet | Other | Oral, one tablet three times a day for 7 days |
|
| Placebo capsules | Other | Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5. |
|
| proportion of initially symtomatic subjects with disappearance of clinical symptoms | Days | Day14 and Day 21 |
| proportion of initially asymtomatic subjects with appearance of new clinical symptoms | Days | Day14 and Day 21 |
| proportions of subjects with potentially medication- related adverse events | grades | 7 day |
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| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |