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Emerging evidence does not support the use of HCQ for treatment or prevention of SARS -CoV2 infection. No pts have been enrolled.
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This study is being done to see if hydroxychloroquine is an effective treatment for COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - hydroxycholoroquine | Experimental | 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. |
|
| Arm B - placebo | Placebo Comparator | Participants will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI) | Clinical improvement is defined as a composite endpoint of a two-point clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI). The OSCI is an ordinal scale of 9 severity levels (from 0 to 8) for COVID-19 | 14 days |
| Number of participants requiring mechanical ventilation for respiratory failure | Clinical improvement is defined as no mechanical ventilation for respiratory failure attributed to SARS-CoV-2 within 14 days of randomization. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Genovefa Papanicolaou, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan - Kettering Cancer Center | New York | New York | 10021 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Placebo | Other | Participants will receive masked placebo given as 2 tablets orally q12h for 2 doses on day 1, followed by 1 tablet orally q12h for days 2-5. |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |