Chloroquine Diphosphate for the Treatment of Severe Acute Respiratory Syndrome Secondary to SARS-CoV2 (CloroCOVID19)
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ClinicalTrials.gov Identifier: NCT04323527 |
Recruitment Status :
Completed
First Posted : March 26, 2020
Last Update Posted : August 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
SARS-CoV Infection Severe Acute Respiratory Syndrome (SARS) Pneumonia | Drug: Chloroquine diphosphate | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 278 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Chloroquine Diphosphate for the Treatment of Hospitalized Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV2: a Phase IIb, Double-blind, Randomized Adaptive Clinical Trial |
Actual Study Start Date : | March 23, 2020 |
Actual Primary Completion Date : | May 7, 2020 |
Actual Study Completion Date : | June 7, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Low Dose Chloroquine Diphosphate (5 days) (Study stage 1) - Clorocovid 1
Low dose chloroquine group consists of 450 mg bid (3 tablets of 150 mg + 1 placebo tablet, every 12 hours) on D1, 3x150mg tablets + 1 placebo followed by 4 placebo tablets 12h later from D2 to D5, and 4 placebo tablets every 12 hours, D6-D10 . Oral administration or via nasogastric tube in case of orotracheal intubation. (this was the first stage of the original study and was approved by the Brazilian IRB on 23/March/2020).
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Drug: Chloroquine diphosphate
150mg chloroquine diphosphate tablets. Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the clinicaltrials.gov refers to chloroquine base (in mg).
Other Name: chloroquine |
Active Comparator: High Dose Chloroquine Diphosphate (10 days) (Study stage 1) - Clorocovid 1
High dose chloroquine group consists of 600 mg bid (4 tablets of 150 mg, every 12 hours) for 10 days. Oral administration or via nasogastric tube in case of orotracheal intubation. (this was the first stage of the original study and was approved by the Brazilian IRB on 23/March/2020).
|
Drug: Chloroquine diphosphate
150mg chloroquine diphosphate tablets. Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the clinicaltrials.gov refers to chloroquine base (in mg).
Other Name: chloroquine |
Placebo Comparator: Placebo (5 days) (Study stage 2) - Clorocovid 3
Placebo group consists of 3 placebo tablets bid (day 1), and 3 placebo tablets once daily from D2 to D5. Oral administration or via a nasogastric tube in case of orotracheal intubation. (this was a second stage of the original study and was approved by the Brazilian IRB on 03/May/2020).
|
Drug: Chloroquine diphosphate
150mg chloroquine diphosphate tablets. Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the clinicaltrials.gov refers to chloroquine base (in mg).
Other Name: chloroquine |
Active Comparator: Low Dose Chloroquine Diphosphate (5 days) (Study stage 2) - Clorocovid 3
Low dose chloroquine group consisted of 450 mg bid (3 tablets of 150 mg) on D1, and 3x150mg tablet once daily from D2 to D5. Oral administration or via a nasogastric tube in case of orotracheal intubation. (this was a second stage of the original study and was approved by the Brazilian IRB on 03/May/2020).
|
Drug: Chloroquine diphosphate
150mg chloroquine diphosphate tablets. Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the clinicaltrials.gov refers to chloroquine base (in mg).
Other Name: chloroquine |
- Mortality rate reduction of 50% by day 28 [ Time Frame: 28 days after randomization ]proportion of deaths at day 28 between groups compared
- Absolute mortality on days 7 and 14 [ Time Frame: 7 and 14 days after first dose ]number of deaths at days 7 and 14 between groups compared
- Improvement in overall subject's clinical status assessed in standardized clinical questionnaires on days 14 and 28 [ Time Frame: 14 and 28 days after first dose ]clinical status
- Improvement in daily clinical status assessed in standardized clinical questionnaires during hospitalization [ Time Frame: during and after intervention, up to 28 days ]clinical status
- Duration of supplemental oxygen (if applicable) [ Time Frame: during and after intervention, up to 28 days ]supplemental oxygen
- Duration of mechanical ventilation (if applicable) [ Time Frame: during and after intervention, up to 28 days ]mechanical ventilation
- Absolute duration of hospital stay in days [ Time Frame: during and after intervention, up to 28 days ]hospitalization
- Prevalence of grade 3 and 4 adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events grade 3 and 4
- Prevalence of serious adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events
- Change in serum creatinine level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum creatinine compared to baseline
- Change in serum troponin I level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum troponin I compared to baseline
- Change in serum aspartate aminotransferase level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
- Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
- Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
- Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
- Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death

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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:
- Male and female participants aged over 18 years old
- Hospitalized
-
presenting:
- respiratory rate higher than 24 breathing incursions per minute AND/OR
- heart rate higher than 125 beats per minute (in the absence of fever) AND/OR
- peripheral oxygen saturation lower than 90% in ambient air AND/OR
- shock (defined as mean arterial pressure less than 65 mmHg, requiring vasopressor or oliguria or lowering level of consciousness)
Exclusion Criteria:
• None.

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): NCT04323527
Brazil | |
Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz | |
Manaus, Amazonas, Brazil, 69093-415 |
Responsible Party: | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado |
ClinicalTrials.gov Identifier: | NCT04323527 |
Other Study ID Numbers: |
CAAE: 30152620.1.0000.0005 |
First Posted: | March 26, 2020 Key Record Dates |
Last Update Posted: | August 9, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | all patient data will be shared after study publication |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | after study publication |
Access Criteria: | upon request to researchers |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 SARS-CoV Infection Severe Acute Respiratory Syndrome (SARS) Pneumonia Chloroquine Diphosphate Clinical trial |
Chloroquine Chloroquine diphosphate Pneumonia Severe Acute Respiratory Syndrome Syndrome Disease Pathologic Processes Infections Respiratory Tract Infections Lung Diseases Respiratory Tract Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Virus Diseases Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antimalarials Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides |