- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04303299
Fight COVID-19 Trial (FIGHT-COVID-19)
A 6 Week Prospective, Open Label, Randomized, in Multicenter Study of, Oseltamivir Plus Hydroxychloroquine Versus Lopipinavir/ Ritonavir Plus Oseltamivir Versus Darunavir/ Ritonavir Plus Oseltamivir Plus Hydroxychloroquine in Mild COVID-19 AND Lopipinavir/ Ritonavir Plus Oseltamivir Versus Favipiravir Plus Lopipinavir / Ritonavir Versus Darunavir/ Ritonavir Plus Oseltamivir Plus Hydroxychloroquine Versus Favipiravir Plus Darunavir and Ritonavir Plus Hydroxychloroquine in Moderate to Critically Ill COVID-19
Study Overview
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 analysed in the efficacy of treatment. For the pair-wise comparison, 2-sided p-value was used to ensure that the overall Type I error=0.05. Beta error 80%. Demographic and safety analyses were based on the summary of descriptive statistics.
Pre-randomization Phase The pre-randomization phase consisted of a screening period (0 to 1 day prior to randomization).
Screening Period (Day -1 to 0) At the screening visit and prior to performance of any study procedures, the investigators would explain the details of the study and the subject would have to sign on the written informed consent, exclusion criteria, and inclusion criteria Each subject who was willing to enrol into the study was asked about their medical history as well as their recent and current medications being taken. All enrolled subjects were asked to undertake an initial physical examination and had to satisfy the criteria for the inclusion /exclusion before being enrolled into the study.
All patients were asked to complete physical examination, CXR, CBC plt, proBNP, High sensitive C reactive protein and Laboratory blood (livers tests, haematology,) examinations, urine pregnancy test) were performed amount 5.5 mL for safety reasons. Nasopharyngeal swabs were collected to detect the ORF 1ab and E genes (sensitivity: 1000 copies per milliliter) by polymerase chain reactions. Will be performed The inclusion visit included the following examination and tests: - physical examination,- vital signs,- weight,- CBC laboratory test result,-Chest X ray or CT chest Blood for plasma cytokine assay -Pro BNP and High sensitive C reactive protein, D dimer Treatment period All patient will be treated with specific arm for 10-14 days or until negative for Nasopharyngeal swabs were collected to detect the ORF 1ab and E genes of SARS -CoV-2 for 3 consecutive tests every 24 -48 hours. ECG monitoring for prolonged QTcB in Hydroxychloroquine arm will be closed monitored The quarantine period will be performed for 7-14 days after swab negative All cases may be treated with Antibiotics as prophylaxis or specific treatment Other standard treatment will be allowed for investigator judgments. CXR nasoparyngeal swab will be performed every 1-2 days or up to investigator judgments Follow up Visits Patient will be check up CXR and CT scan, nasoparyngeal swab will be performed every 1-2 day until negative test and until 4-6 weeks or clinical complete recovery.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bangkok, Thailand, 10400
- Assistant Professor Subsai Kongsaengdao
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Oseltamivir plus Chloroquine in Mild COVID19
Oseltamivir 300mg ( or 4-6 mg/kg) per day plus Hydroxychloroquine 800 mg per day In mild COVID19
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Anti virus treatment
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EXPERIMENTAL: Darunavir and Ritonavir plus oseltamivir
Darunavir 400 mg every 8 hours Ritonavir 200 mg (or 2.5 mg/kg ) per day plus plus Oseltamivir 300mg ( or 4-6 mg/kg) per day plus Hydroxychloroquine 400mg per day in Mild COVID19
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Anti virus treatment
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EXPERIMENTAL: Lopinavir and Ritonavir plus Oseltamivir in mild COVID19
Lopinavir 800 mg ( or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day In mild COVID19
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Anti virus treatment
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EXPERIMENTAL: Lopinavir and Ritonavir Oseltamivir moderate to severe COVID19
Lopinavir 800 mg ( or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day In moderate to critically ill COVID19
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Anti virus treatment
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EXPERIMENTAL: Favipiravir lopinavir /Ritonavir for mod. To severe
Lopinavir 800 mg (or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day in Mild COVID19 In moderate to critically ill COVID19
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Anti virus treatment
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EXPERIMENTAL: Darunavir /ritonavir oseltamivir chloroquine mod-severe
Darunavir 400 mg every 8 hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg (or 4-6 mg /kg ) per day plus Hydroxychloroquine 400 mg per day In moderate to critically ill COVID19
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Anti virus treatment
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EXPERIMENTAL: Darunavir /ritonavir favipiravir chloroquine mod-severe
Darunavir 400 mg every 8 hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Hydroxychloroquine 400 mg per day In moderate to critically ill COVID19
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Anti virus treatment
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NO_INTERVENTION: Conventional Qurantine
Patient who unwilling to treatment and willing to quarantine in mild COVID19
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SARS-CoV-2 eradication time
Time Frame: Up to 24 weeks
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Eradication of nasopharyngeal SARS-CoV-2
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Up to 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patient with Death
Time Frame: Up to 24 weeks
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Any death after treatment adjusted by initial severity in each arm
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Up to 24 weeks
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Number of patient with Recovery adjusted by initial severity in each arm
Time Frame: Up to 24 weeks
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Normal pulmonary function, normal O2 saturation after treatment Adjusted by initial severity in each arm
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Up to 24 weeks
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Number of day With ventilator dependent adjusted by initial severity in each arm
Time Frame: Up to 24 weeks
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Number of day with ventilator assistant
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Up to 24 weeks
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Number of patient developed Acute Respiratory Distress Syndrome After treatment
Time Frame: Up to 24 weeks
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Number of patient developed new ARDS
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Up to 24 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patient with Acute Respiratory Distress Syndrome Recovery
Time Frame: Up to 24 weeks
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Acute Respiratory Distress Syndrome Recovery rate
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Up to 24 weeks
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Time to recovery
Time Frame: Up to 24 Weeks
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The time to recovery was defined as the time between the first day of antiviral treatment or hospitalization to the day when there was no further requirement for antiviral medication or on-going medical care or the day of discharge from the hospital.
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Up to 24 Weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TH-DMS-COVID19 study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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Data references
Information identifier: Thai government data
- News
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Reference review data set of DMS database
Information comments: Preliminary Database result of prospective open study of 119 pneumonia ( another population)patient ( it is not data from this RCT)
- Reference News
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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