Status:
COMPLETED
Fight COVID-19 Trial
Lead Sponsor:
Department of Medical Services Ministry of Public Health of Thailand
Conditions:
SARS-COV-2 Infections
COVID-19
Eligibility:
All Genders
16-100 years
Phase:
PHASE3
Brief Summary
A 6-Week Prospective, Open label, Randomized, in Multicenter Study of, Oseltamivir 300mg per day plus Hydroxychloroquine 800 mg per day versus Combination of Lopipinavir 800mg (or 10 mg/kg ) per day a...
Detailed Description
Overall Study Design and Plan Various Combination of Protease inhibitors, Oseltamivir, Favipiravir, and Chloroquin for treatment of COVID-19. Non parametric and parametric statistical analysis will be...
Eligibility Criteria
Inclusion
- The subject has to grant permission to enter into the study by signing and dating the informed consent form before completing any study-related procedure such as any assessment or evaluation not related to the normal medical care of the subject.
- Able to give written inform consent and retained one copy of the consent form
- Male or female subject, aged between 16 - 100 years old.
- Subject diagnosed to be COVID19
- Female subject in good health and sexually active was instructed by the investigator to avoid pregnancy during the study and to use condom or other contraceptive measure if necessary. The subject was required to have a negative urine pregnancy test before being eligible for the study. (At each of the subsequent visit, a urine pregnancy test was performed).
- Subject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment.and compliance to quarantine procedure 7-14 days after treatment
Exclusion
- The subject was pregnant or lactating.
- The subject was a female at risk of pregnancy during the study and not taking adequate precautions against pregnancy.
- The subject had a known hypersensitivity to any of the test materials or related compounds.
- The subject was unable or unwilling to comply fully with the protocol.
- Treatment with investigational drug (s) within 6 months before the screening visit.
- The subject had previously entered in this study.
- Patient who planned to schedule elective surgery during the study
- The used of other antiviral agents
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2021
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04303299
Start Date
August 19 2020
End Date
August 28 2021
Last Update
September 2 2021
Active Locations (1)
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1
Assistant Professor Subsai Kongsaengdao
Bangkok, Thailand, 10400