Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection (CloroCOVID19II)
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ClinicalTrials.gov Identifier: NCT04342650 |
Recruitment Status :
Completed
First Posted : April 13, 2020
Last Update Posted : August 9, 2021
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 SARS-CoV Infection Severe Acute Respiratory Syndrome (SARS) Pneumonia Clinical Trial | Drug: Chloroquine Diphosphate Drug: Placebo oral tablet | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 152 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase IIb Study to Evaluate the Efficacy and Safety of Chloroquine Diphosphate in the Treatment of Patients With Comorbidities, Without Severe Acute Respiratory Syndrome, Under the New Coronavirus (SARS-CoV2): a Double-blind, Randomized, Placebo-controlled Clinical Trial |
Actual Study Start Date : | April 8, 2020 |
Actual Primary Completion Date : | May 14, 2020 |
Actual Study Completion Date : | June 8, 2020 |

Arm | Intervention/treatment |
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Active Comparator: Intervention
CQ 450mg twice daily (3 tablets of 150mg, every 12 hours) on day 1, followed by CQ 450mg once daily (3 tablets of 150mg) from D2 to D5. Oral administration.
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Drug: Chloroquine Diphosphate
150mg 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
Placebo tables of equal characteristics and duration of treatment.
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Drug: Placebo oral tablet
150mg placebo tablets |
- Proportion of patients with onset of severe acute respiratory syndrome (SARS) [ Time Frame: 7 days after randomization ]Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.
- Mortality rate [ Time Frame: after randomization, up to 28 days ]Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization
- Number of participants in need of intensive care support [ Time Frame: during and after intervention, up to 28 days ]Proportion of participants in need and duration of intensive care support after randomization
- Viral concentration [ Time Frame: After randomization, up to 7 days ]Viral load change in blood and oropharyngeal swab samples
- Cumulative incidence of serious adverse events [ Time Frame: During and after intervention, up to 28 days ]Incidence of serious adverse events during and after treatment
- Cumulative incidence of grade 3 and 4 adverse events [ Time Frame: During and after intervention, up to 28 days ]Incidence of grade 3 and 4 adverse events during and after treatment
- Proportion of patients with discontinued treatment [ Time Frame: after randomization, up to 28 days ]proportion of discontinuation or temporary suspension of treatment (for any reason)
- Incidence of cardiac lesions [ Time Frame: after randomization, up to 120 days ]proportion of patients with increased levels of troponin I
- Incidence of cardiac disfunctions [ Time Frame: after randomization, up to 120 days ]proportion and magnitude of QTcF interval increases higher than 500ms
- Change in respiratory capacity [ Time Frame: Day 120 after randomization ]Changes measured on day 120 will be compared to baseline, through spirometry.

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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:
- Suspected cases of COVID-19, due to clinical and radiological data, during the epidemic;
- Adult aged 18 or over, at the time of inclusion
- Not having severe acute respiratory syndrome (SARS), that is, not using mechanical ventilation or supplemental oxygen, peripheral oxygen saturation> 94% in room air, and having a respiratory rate below 24 incursions per minute.
- Patients with comorbidities only, due to the increased risk of developing SARS
Exclusion Criteria:
1. Patients with chronic use of drugs known to prolong QTc interval.

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): NCT04342650
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: | NCT04342650 |
Other Study ID Numbers: |
CAAE: 30504220.5.0000.0005 |
First Posted: | April 13, 2020 Key Record Dates |
Last Update Posted: | August 9, 2021 |
Last Verified: | July 2020 |
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 formal request to researchers. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infections COVID-19 Severe Acute Respiratory Syndrome Syndrome Disease Pathologic Processes Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases |
Respiratory Tract Diseases Chloroquine Chloroquine diphosphate 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 |