Is nebulised Homo-Harringtonine (HHT) efficacious in clearing the viral load in patients with SARS-CoV-2 who are under the care of intermediate care center at Arachchikanda, Galle?

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 computer derived random number generating table by a third party. This third party does not include any investigator or staff in the Intermediate care center (ICC) At the time of enrollment of participants to the study the third party will be contacted by the staff of the ICC to assign the patient to the treatment or placebo group. The assignment will be recorded by the third party and would not expose concealed allocation to the researchers until the analysis of the data would be completed. The only exception would be if the Physician in charge of the patient/s request the randomization for placebo or drug for the management of a complication suspected to be due to the drug, then it would be divulged to the physician by the third party.

Intervention group: On day 1, HHT would be administered twice daily at a dosage of 0.3 mg (half of the calculated dose) in 3 ml of normal saline, if patients could tolerate the dose, 0.6mg in 3 ml of normal saline would be administered twice per day for 5 days from day 2 onwards. If the CT value of day 5 indicates viral clearance with a negative PCR, HHT administration would be discontinued and if not, it will be continued until day 7 is completed.

Control group: 3 ml of 0.9% saline twice daily would be administered for 7 consecutive days as placebo to the control group

Standard care will be provided to both groups. Standard care at ICC is the care stipulated in the guideline of the Ministry of Health on management of asymptomatic or minimally symptomatic patients with COVID-19 infection. This includes paracetamol for the fever and no other medication [Reference MOH – Clinical management guideline on management of COVID-19 infection with mild or asymptomatic patients].

1. Previously healthy adult volunteers between the age of 30 to 60 years
2. Both male and female
3. Positive PCR for SARS – Cov 2 (COVID-19) with a CT value of less than 25
4. With no or mild symptoms of COVID-19 such as fever, rhinorrhoea, anosmia and sore throat

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 <5 times the ULN, moderate if 5-10 times the ULN or marked 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