Status:
COMPLETED
Prevention of Complications (SARS-CoV-2): Clinical Study
Lead Sponsor:
Universidade do Vale do Sapucai
Collaborating Sponsors:
Pfizer
Apsen Farmaceutica S.A.
Conditions:
Complication
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Viral diseases have always posed a threat to public health. Recently, the SARS-Cov2 virus spread in an epidemic that began in China and soon spread globally, making its study extremely relevant, in or...
Detailed Description
The early administration of HCQ or in association with apixaban, could prevent worsening of suspected COVID-19, as well as preventing hospitalizations and the need for intensive treatment. In patients...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with suspected or confirmed covid-19, above 18 years old
- Patients with time between symptom onset and inclusion ≤ 14 days
- Patients with time between hospital stay and inclusion ≤ 48 hours
- Exclusion criteria:
- Patients tested negative for covid-19 by rt-pcr, serological or rapid test method
- Patients unable to swallow for any reason
- Patients with an extended qt interval, defined as a corrected qt (qtc) for heart rate above 450 ms for men and 470 ms for women
- Patients with liver toxicity, defined as ast / alt or increased bilirubin
- Patients with ventricular arrhythmias
- Patients with bleeding, major hematoma or blood dyscrasia;
- Patients who, at any time during the process, choose to give up participating in the study
Exclusion
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2020
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04788355
Start Date
July 1 2020
End Date
December 23 2020
Last Update
March 9 2021
Active Locations (1)
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1
Univás
Pouso Alegre, Minas Gerais, Brazil, 37550000