SARS CoV-2 infection
Conditions
Interventions
Study setting:
Intermediate care centre for the patients with SARS CoV- 2 at Arachchikanda, Galle District, Sri Lanka
Randomization method:
Patients would be randomized to two equal groups with compu
Sponsors
Mr Jian Li
Eligibility
Inclusion criteria
Inclusion criteria: 1. Previously healthy adult volunteers between the age of 30 to 60 years 2. Both male and female 2. Positive PCR for SARS – Cov 2 (COVID-19) with a CT value of less than 25 3. With no or mild symptoms of COVID-19 such as fever, rhinorrhoea, anosmia and sore throat
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to drugs 2. According to the current trial implementation of the latest version of the "New Coronavirus Infection Pneumonia Diagnosis and Treatment Plan", the patient is diagnosed as a critically ill patient with novel coronavirus pneumonia; 3. Combined with severe liver disease (Total bilirubin:TBIL >=2 ULN, alanine transaminase; ALT, aspartate transaminase; AST >=5 ULN (Abnormalities in these liver enzymes are generally considered mild if 10 times the ULN) 4. Patients with severe renal insufficiency (glomerular filtration rate <=60 mL/min/1.73m2) or who are receiving continuous renal replacement therapy, hemodialysis, and peritoneal dialysis; 5. Patients who have severe breathing difficulties and cannot complete the self-aerosolized drug inhalation; 6. Patients with hematological tumors; 7. Patients who have used antiviral drugs in the past 2 months, such as interferon, lopinavir, ritonavir, remdesivir, etc.,or are receiving other antiviral drugs; 8. Women who are pregnant or breastfeeding or have a birth plan during the trial period and within 6 months after the end of the trial; 9. Are participating in other clinical trials or are using experimental drugs; 10. Rehabilitation plasma therapy for patients with COVID-19; 11. Are using Aurvedic medicine for treatment; 12. Patients with diabetes, hypertension and obese people; 13. According to the judgment of the research team, there are other circumstances that are not suitable for participating in this trial. Eg; Geographical distance for the research centre for follow up subjects. 14. Vulnerable people Eg; Prisoners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change of viral load with daily PCR and CT value. [Daily for 7 days, day 10 and day 14] | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom progression during the stay in the intermediate treatment centre assessed by clinical review. Symptoms monitored are Fever, Malaise, Body aches, Sore throat, Rhinorrhea and nasal discharge, Nasal congestion, Loss of appetite, Cold, Muscle aches, Chest pain, Loss of smell, Shortness of breath, Wheezing, Diarrhoea, Vomiting, Abdominal pain, Rash, Conjunctivitis, Rhinorrhea [Daily in the intermediate care centre] Development of complications in the two groups in relation to COVID-19 or the treatment with HHT in terms of laboratory investigations Complications/ the laboratory investigations monitored for abnormalities are as follows Complications Acute respiratory failure, Pneumonia, Acute respiratory distress syndrome (ARDS), Acute liver injury, Secondary infection, Acute kidney injury Septic shock Laboratory investigations Patients will have their PCR with the CT value at base line, day 1-7 of administration of HHT/placebo, day 10 and day 14 done during the study. Full blood count (FBC), capillary blood sugar (CBS), serum electrolytes (SE), serum creatinine (SC), liver enzymes (SGPT/SGOT), urine full report (UFR), and blood picture would be performed at baseline, day 5, day10 and day 14 prior to discharge, day 30, 60, 90. Any abnormal results will be followed up for 1year Human Clara Cell Protein (HCCP) and human Surfactant Protein-D (SP-D) would be performed at baseline, day 5,10, 14, 30, 60, 90 and I year. [Baseline, day 5, day10 and day 14 prior to discharge, day 30, 60, 90 Any abnormal results will be followed up for 1year ] Pulmonary inflammatory response with HCCP and SP-D [Baseline, day 5, day 10 and day 14 prior to discharge, day 30, 60, 90 Any abnormal results will be followed up for 1year ] The patients would be followed up to report any adverse effect of nebulized HHT on lungs Common side effects of HHT include thrombocytopenia, anemia, neutropenia, diarrhoea, constipation, nausea, vomiting, abdominal pain, weakness, fat | — |
Countries
Sri Lanka
Contacts
Public ContactSujeewa Amarasena
Senior Professor and Vice Chancellor
Outcome results
None listed