COVID-19 trials registries data warehouse

https://slctr.lk/trials/slctr-2021-024

Sujeewa Amarasena

sujeewa_amarasena@yahoo.com

2021-08-05

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

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

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

2

Mr Jian Li

30

60

Sri Lanka

Mild disease at enrollment

1: Mild disease at enrollment

3015

Percentage change of viral load with daily PCR and CT value. [Daily for 7 days; day 10 and day 14]

Phase 2/Phase 3

[{"arm_notes": "nebulized", "treatment_id": 1973, "treatment_name": "Omacetaxine mepesuccinate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]