Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection (CloroCOVID19II)
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|ClinicalTrials.gov Identifier: NCT04342650|
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : April 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|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)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
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.
Drug: Chloroquine Diphosphate
Other Name: chloroquine
Placebo Comparator: Placebo
Placebo tables of equal characteristics and duration of treatment.
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.
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
|Contact: Marcus Lacerda, MD||+55 92 99114 firstname.lastname@example.org|
|Contact: Fernando Val, PhD||+55 92 99116 email@example.com|
|Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz||Recruiting|
|Manaus, Amazonas, Brazil, 69093-415|
|Contact: Mayla Borba, MD +5592981519122|