Fight COVID-19 Trial
Condition: SARS-COV-2 Infections; COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

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 and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or
      4-6 mg /kg ) per day versus Combination of Darunavir 400 mg every 8 hours plus ritonavir 200
      mg (or 2.5 mg/kg ) per day plus Oseltamivir 300mg ( or 4-6 mg /kg ) per day plus
      Hydroxychloroquine 400 mg per day in mild COVID-19 and Combination of Lopipinavir 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 versus 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 Lopipinavir 800 mg ( or 10 mg/kg ) per day and
      Ritonavir 200 mg ( or 2.5 mg/kg ) per day versus Combination of Darunavir 400 mg every 8
      hours plus ritonavir 200 mg (or 2.5 mg/kg ) plus Oseltamivir 300 mg (or 4-6 mg /kg ) per day
      plus Hydroxychloroquine 400 mg per day versus 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 Darunavir 400 mg every 8
      hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Hydroxychloroquine 400 mg per day in
      moderate to critically illness in COVID-19
    

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.
    

Intervention name(s): Oral
Intervention type(s): Drug
Intervention description(s): Anti virus treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment