| Study name |
Clinical trial of APMV2020 in Covid 19 subjects |
| Methods |
Trial design: randomised, parallel‐group, active controlled trial Type of publication: trial registry Setting: outpatient Recruitment dates: open to recruitment Country: India Language: English Number of centres: 2 Inclusion criteria: age: 18 to 60 years, confirmed COVID‐19 patient with positive RT‐PCR test, mild symptomatic patients having no signs of severe disease, home/institutional quarantined patients with no necessity of dedicated hospital admission at the time of screening, participant willing to provide consent and follow up for study duration Exclusion criteria: patients with autoimmune disease or self‐reports HIV or syphilis infection, patients suffering from disorders where aspirin is contraindicated and/or as per the discretion of investigator, proves to be unfit for the study as per the investigator's discretion, pregnant or lactating women, requiring hospital admission at screening, any other comorbidity which is critical stage at screening which in investigator discretion finds subject not suitable for the trial participation Trial registration number: CTRI/2021/06/034254 Date of trial registration: 15 June 2021 Prospective completion date: NR |
| Participants |
Age: 18 to 60 years Gender: female/male Ethnicity: NR Number of participants (recruited/allocated/evaluated): 60 planned Severity of disease: mild SARS‐CoV‐2 Infection (COVID‐19) (see inclusion criteria) Additional diagnosis: NR Previous treatments (e.g. experimental drugs, oxygen therapy, ventilation): NR |
| Interventions |
Tablet containing aspirin and promethazine hydrochloride orally twice a day for 10 days, dose NR Multivitamin and multimineral tablet orally twice a day for 10 days, dose NR
Along with standard care as per MoHFW guidelines for 10 days
Concomitant therapy: NR Treatment cross‐overs: NR Duration of follow‐up: NR Compliance with assigned treatment: NR
|
| Outcomes |
Primary outcomes
Improvement of clinical symptoms including fever, headache, diarrhoea, breathlessness, cough, anosmia, fatigue and myalgia on 10 point VAS scale 0‐ no symptom and 10‐severe symptom Reduction in elevated levels of inflammatory markers such as CRP, LDH ferritin and D‐dimer Changes in blood oxygen level SPO2, time point: screening day 3, day 5 and day 10
Secondary outcomes
Requirement of hospitalisation Requirement of admission to intensive care unit Tolerability Safety evident by adverse events: time point: screening days 3, 5 and 10
Additional outcomes: NR |
| Starting date |
NR |
| Contact information |
Mr Taasin Ahmed Shah,
912225817126, tdcruz@meyer.co.in
Ms Tania Dcruz, 912225817126, tdcruz@meyer.co.in |
| Notes |
Sponsors/funding: Meyer Organics Pvt. Ltd A‐303, Road No. 32, Wagle Estate, Thane ‐ 400 604. (India) |
