CloroCOVID19II
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
Sponsor study identifier
interventional
152
1 country
1
Study Start
April 8, 2020
Actual (reported)Primary Completion
May 14, 2020
Actual (reported)Study Completion
June 8, 2020
Actual (reported)This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 8, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 4, 2020
Actual (reported)April 8, 2020
Actual (reported)April 13, 2020
Actual (reported)May 14, 2020
Actual (reported)June 8, 2020
Actual (reported)Proportion of patients with onset of severe acute respiratory syndrome (SARS)
Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.
7 days after randomization
Mortality rate
after randomization, up to 28 days
Number of participants in need of intensive care support
during and after intervention, up to 28 days
Viral concentration
After randomization, up to 7 days
Cumulative incidence of serious adverse events
During and after intervention, up to 28 days
Cumulative incidence of grade 3 and 4 adverse events
During and after intervention, up to 28 days
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.
Placebo tables of equal characteristics and duration of treatment.
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).
150mg placebo tablets
Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz
Manaus, Amazonas, 69093-415, Brazil
152 participants (actual enrollment reported by the registry).
First Submitted
April 4, 2020
First Posted
April 13, 2020
Study Start
April 8, 2020
Actual (reported)A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 14, 2020
Actual (reported)Study Completion
June 8, 2020
Actual (reported)Last Updated
August 9, 2021
Record last verified: 2020-07
all patient data will be shared after study publication
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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