COVID-19
Conditions
Interventions
This study will be conducted at the National Institute of Infectious Diseases, Angoda, Sri Lanka.
Patients who fulfill the inclusion criteria will be randomized into two groups using computer-generate
Sponsors
Link Natural Products (Pvt) Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Patients who are over 18 years of age • Both male and female • Confirmed diagnosis of COVID-19 by a PCR test nasopharyngeal/throat/sputum swab within 48 hours prior to randomization [at hospital reception before admission] • Onset of one or more of COVID-19 related symptoms and/or signs of mild to moderate disease within 96 hours prior to randomization. [Symptoms of mild disease are: i. Fever ii. Cough iii. Sore throat iv. Malaise v. Headache vi. Muscle pain vii. Gastrointestinal symptoms. Signs of moderate disease (in addition to symptoms of mild disease) i. Shortness of breath with exertion ii.Respiratory rate >= 20 but 93% of room air iv.Heart rate >= 90/min but <125/min]
Exclusion criteria
Exclusion criteria: * Patients who have a known allergy to the Ayurveda drug Sudarshana Cúrna or Link Natural Sudarshana Tablet (LNST) or any of its components. * Pregnant women (confirmed or suspected with a history of a missing menstrual period for more than a week) * Breast-feeding mothers * Patients with cerebrovascular disease, or stroke, or ischaemic heart disease, or diabetes, or hypertension, or history of liver disease, or renal disease (all the patients will be screened for diabetes (DM), or high blood pressure (BP). Even without a history DM or high BP, if the random blood sugar done on admission is >200 mg/dL, or if the systolic blood pressure is >140 or diastolic blood pressure is > 90 mmHg, they will be excluded from the study) * Patients with severe disease as indicated by SpO2 =30 per minute, heart rate >=125 per minute (38c) *Patients with critical disease ie. those who require mechanical ventilation or anticipated impending need for mechanical ventilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 87% reduction of viral burden by measuring semi-quantitative viral RNA of SARS-COV-2 as measured by cycle threshold from nasopharyngeal swabs. (viral burden is calculated using the Ct values as done in BALZE-1 study protocol. Ref. Chen, P.et al. (2020). SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. New England Journal of Medicine.doi:10.1056 /nejmoa2029849) [Day 11 from the date of intervention] Clinical progression using the WHO ordinal outcome scale - WHO Working Group on the Clinical Characterisations and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis 2020. Published Online June 12, 2020. https://doi.org /10.1016/S1473-3099(20)30483-7) [Day 6, 10 and 14 from the date of intervention] | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of symptom score by 50% by day 6 and by 100% by day 10 of intervention ( Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3) as used in the BLAZE-1 study) [Day 6, 10 and 14 of hospital stay] 100% reduction of hospital stay to 14 days [ At discharge from the hospital.] 50% reduction of development of hypoxia (SPO2 <94%. Reference: Wang Y. et al. Remdesivir in adults with severe COVID-19: A randomised,double-blind, placebo-controlled, multicentre trial. Lancet 2020; 395: 1569–78 https://doi.org/10.1016/S0140-6736(20)31022-9) [ Throughout the hospital stay] 100% normalization of C-Reactive protein (CRP), Erythrocyte Sedimentation Rate (ESR), Aspartate aminotransferease (AST), Alanine aminotransferase (ALT), and serum creatinine by day 14 of intervention. [ Every 4th day of hospital stay since enrollment] 50% improvement of lymphopaenia by day 10 and 100% improvement by day 14. (lymphopaenia= lymphocyte count <1•0 × 109/L. Reference: Huang C. et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 15-21 February; 395(10223): 497–506. doi: 10.1016/S0140-6736(20)30183-5) [ Every 4th day of hospital stay since enrollment] [ ] [ ] [] [] [ ] [ ] [] [ ] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. Ananda Wijewickrama
Consultant Physician
Outcome results
None listed