COVID-19, SARS-COV-2 infection
Conditions
Interventions
Study setting(s):
Methsirisewana (affiliated to Teaching Hospital, Anuradhapura) and Nochchiyagama Divisional Hospital (A) –both dedicated COVID-19 treatment centers, Sri Lanka
Method of randomizatio
Sponsors
Ministry of Production, Supply and Regulation of Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. All consenting male and female adults (18–80 years of age) 2. Asymptomatic or mild or moderate disease (as defined in the case definition) 3. Two positive RT-qPCR tests 4. Negative antibody test 5. Cycle threshold (Ct) value <38 at the time of recruitment Case definition: US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research, Centre for Biologics Evaluation and Research. COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry. 2020;(May):1–11.
Exclusion criteria
Exclusion criteria: 1. Pregnant (known pregnancy or positive urine strip test) and lactating females 2. Patients who have ingested Sri Weera Badhra Dhamma Prathishakthi Jeewa Panaya© within the past six weeks 3. Patients with known allergy to the individual ingredients (Bees honey, nutmeg, fennel, raw ginger) of Sri Weera Badhra Dhamma Prathishakthi Jeewa Panaya© 4. Any diagnosed co-morbidity such as diabetes, hypertension, renal disease, liver disease or bronchial asthma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Cycle threshold (Ct) value of the reverse transcriptase, a quantitative PCR test will be the primary outcome measure after three days of the treatment. In this study, Ct value of over 38 (negative RT-qPCR) will be taken as a primary outcome measure Primary outcome would be the percentage of persons having a Ct value over 38 on day 3 (50% in treatment arm and 20% in the control arm – difference of 30%). An effect size (odds ratio) of 4.0 can be detected. [Timepoint: at baseline, day 4 and day 7 from the time of ingestion of the first dose.] | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical outcome of the patients and improvement of symptoms. Fever, loss of smell, cough, loss of taste, sore throat, headache, nasal symptoms, shortness of breath, loss of appetite/ nausea/ vomiting, diarrhea, myalgia/ arthralgia For improvement of symptoms, 50% improvement in treatment arm and 20% in the control arm – difference of 30%: Can detect an effect size (odds ratio) of 4.0. [Timepoint: Clinical symptoms-daily from recruitment for a total of seven days. ] Changes in parameters of full blood count: White cell count more 1×10^9/L (normal white cell count 4.5 to 11.0 × 10^9/L. (Huang & Pranata, 2020). Platelet count 50 × 10^9/L will be considered as an adverse outcome (Wool et al., 2020). To detect an increase of 1x10^9/L the mean white cell count in the control arm compared to the treatment arm – can detect an effect size of 1.32. [Timepoint: At baseline, day 4 and day 7 from the time of ingestion of the first dose. ] Changes in Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT): 3 times the upper limit of normal (In COVID-19 abnormal ALT/AST is expected depending on severity). Patients with abnormal ALT/AST above 3 times normal will from the baseline will be considered as an adverse outcome. Assuming that 30% of patients in the treatment arm and 10% of patients in the control arm will have elevated ALT and/or AST more than 3 times the upper limit of normal – can detect an effect size of 3.86. [Timepoint: At baseline, day 4 and day 7 from the time of ingestion of the first dose.] Renal function impairment: Increase in Serum creatinine (SCr) by > 0.3 mg/dl ( > 26.5 µmol/l) within 48 hours OR increase in SCr to > 1.5 times baseline will be considered as an adverse event (KDIGO criteria, 2012). Using the same assumptions as above for renal impairment (i.e., increase in serum creatinine >0.3 mg/dl from baseline) to be 30% in the treatment arm and 10% in the control arm, an effect size of 3.86 can be detected. [Timepoin | — |
Countries
Sri Lanka
Contacts
Public ContactProfessor Sisira Siribaddana
Professor of Medicine and Consultant Physician
Outcome results
None listed