A clinical study to evaluate efficacy and safety of Camphora tablets in Covid positive patients

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: Intervention1: Camphora tablets: Mild infection: Camphora (1M) 4 pills every 4 hours until symptoms abate. Moderate infection: Camphora (10M) 4 pills every 3 hours until symptoms abate. Severe infection: Camphora (10M) 4 pills every 2 hours until symptoms abate To be taken for 10‐14 days or till discharge Control Intervention1: Placebo: Mild infection: Placebo 4 pills every 4 hours until symptoms abate. Moderate infection: Placebo 4 pills every 3 hours until symptoms abate. Severe infection: Placebo 4 pills every 2 hours until symptoms abate To be taken for 10‐14 days or till discharge CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: This will include determination of the proportion of subjects showing clinical improvement in both the treatment groupsTimepoint: Day 0, Day 7, Day 14 or Discharge SECONDARY OUTCOME: The determination of change in the clinical improvement scale, resolution of fever by Tmax response, overall survival of the subjects, survival to hospital discharge, progression of COVID‐19 associated pneumonitis, number of ICU days, duration of increased supplemental oxygen requirement, change in oxygen requirement, change in cytokine levels and other biomarkers (CRP, CPK, S. Ferritin, LDH, D‐dimer levels) and safety and tolerability of Camphora tablets from baseline to end of treatmentTimepoint: Day 0, Day 7, Day 14, Discharge INCLUSION CRITERIA: 1.Patients who are able to provide a written informed consent or have a legally accepted representative to provide the same. 2.Patients who are proven to be positive for SARS‐CoV‐2 infection, as confirmed by the RT‐PCR test 48 hours prior to the entry into the study. 3.Patients who are admitted with mild / moderate/ severe COVID‐19 (as per MOFHW criteria) for treatment at the hospital 4.Female patients with a negative urine pregnancy test at screening. 5.Patients who are able to take the study drug orally and comply with the study procedures
Epistemonikos ID: d556812d5c7ceb62b1a4dc2ede8e13bde48b1870
First added on: Dec 17, 2020