Investigation of effect of homoeopathic remedy as add on therapy to standard of care (regular treatment) in adult patients with moderate to severe COVID-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/08/027005
- Lead Sponsor
- Homoeocon Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
A subject will be considered eligible for inclusion in this study only if ALL of the following criteria apply:
1. Hospitalized patient with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) (or any other confirmatory test to diagnose SARS-CoV-2 infection if there is such change in guidelines issued time to time by the Government of India, Task Force for COVID or any other concerned authority/body assigned for this purpose) as documented by either of the following:
PCR positive in sample collected < 72 hours prior to randomization; OR
PCR positive in sample collected >= 72 hours prior to randomization with documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.)
2. Subject (or legally acceptable representative) understands and agrees to comply with planned study procedures and provides informed consent prior to initiation of study procedures.
3. Male or non-pregnant female adult >=18 years of age at time of enrolment.
4. Illness with <=12 days duration, and at least one of the following:
Radiographic infiltrates by imaging captured during the period between date of admission to date of enrolment that is chest x-ray, CT scan, lung ultrasound.
Presence of clinical features of dyspnea and or hypoxia, fever cough including Respiratory rate > 24 breaths/min OR SpO2 < or equal to 94 on room air
Requiring supplemental oxygen
Requiring HFNO/NIV
5. Women of childbearing potential must agree either to abstinence or to use at least one primary form of contraception not including hormonal contraception from the time of screening till end of the study.
6. Subject (or legally acceptable representative) agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 till end of this study.
7. Subject (or legally acceptable representative) is willing to be a study participant and to accept randomization to any assigned treatment arm.
1. Physician makes a decision that trial involvement is not in patientâ??s best interest, or there is any condition that does not allow the protocol to be followed safely.
2. There is anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
3. Patient already in another clinical trial of an experimental treatment for COVID-19
4. Patient has a PaO2/FiO2 ratio < 200 or is requiring IMV/ECMO at baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TTR (Time to Recovery)Timepoint: Censored at Day 28 <br/ ><br>TTR is defined as the time (in days) from randomization of study treatment (active or placebo) until Day of recovery. Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the eight category ordinal scale
- Secondary Outcome Measures
Name Time Method