Clinical Trial to assess benefit of adding Chlorpromazine to the current Standard of Care in treating patients who are moderately infected with COVID-19. Â
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2021/06/034064
- Lead Sponsor
- CSIRIICT
- Brief Summary
**Study Design:**Open-label, Multicentre, Randomized, Parallel-Group, Two arm study
To compare the Time to Response to treatment with Standard of Care Chlorpromazine CPZ Versus SOC alone
TTR is defined as the reduction of at least one level of severity relative to the baseline as per the World Health Organization [WHO] 8 - point ordinal scale for clinical improvement. The median time to produce the first response measured as a reduction in severity will be compared between the treatment arm SOC PLUS CPZ and the comparator
The primary measure of the efficacy of the drug chlorpromazine will be the reduction in the number of days required to produce the first response. This response is defined as the reduction in the severity of the disease
To demonstrate that greater clinical improvement is seen on treatment with SOC PLUS Chlorpromazine versus SOC alone. Clinical improvement will be monitored post-dosing and will be assessed based on the following parameters
1. A decrease in the swab viral load of SARS COV 2
2. A decrease in inflammatory markers will be measured at screening and End of Treatment EOT. The inflammatory markers which will be evaluated are: C Reactive Protein , lymphocytes, Interleukin-6 , Lactate dehydrogenase , inflammatory cytokines, NT-ProBNP, hScTn, Platelet count, Sr. Ferritin and coagulation factors like platelets, D-Dimer
The study population will comprise male & non-pregnant, non-lactating female patients between 18-65 years who are evaluated as moderate cases of COVID19. Moderate cases will be defined as per the ICMR guidelines and treating Investigator assessment. The selection of the participants will be strict as per the eligibility criteria described in the protocol. The recruitment will be voluntary and without any coercion. Participants will be fairly selected and no particular group will be coerced to participate. All participants will be enrolled only after obtaining valid written informed consent. In case a vulnerable population is to be enrolled, the enrolment will be properly justified so that at all times safety, wellbeing, and rights of the
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 176
- Documented COVID-19 infection as observed by positive RT-PCR for SARS-CoV-2 on the day of screening.
- Adult having moderate form of infection defined as presence of clinical features of dyspnea, and or hypoxia, fever, cough including spO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute.
- Patients suffering from severe Covid-19 disease as per the physician’s discretion.
- History of Chronic illness will be obtained and those with a history of active, ongoing disease will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time To Response TTR measured as the number of days since randomization in which there is reduction of at least one severity level of the disease measured using a World Health Organization 8 Point Ordinal Scale for Clinical Improvement WHO OSCI. Baseline and 3 weeks (21 days)
- Secondary Outcome Measures
Name Time Method A decrease in the swab viral load of SARSCOV2 Reduction in the need for intensive care in the treatment arm versus SOC A decrease in inflammatory markers will be measured at screening and End of Treatment
Trial Locations
- Locations (7)
Government General and Chest Hospital
🇮🇳Hyderabad, TELANGANA, India
Government Medical College and Government General Hospital
🇮🇳Srikakulam, ANDHRA PRADESH, India
Great Eastern Medical College and Hospital
🇮🇳Srikakulam, ANDHRA PRADESH, India
Maharaja Agrasen Super speciality Hospital
🇮🇳Jaipur, RAJASTHAN, India
Mallareddy Medical College for Women
🇮🇳Hyderabad, TELANGANA, India
Shravan Hospital and Kidney Institute,
🇮🇳Nagpur, MAHARASHTRA, India
St George Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Government General and Chest Hospital🇮🇳Hyderabad, TELANGANA, IndiaDr KarthikPrincipal investigator9849424240vkarthikrao@gmail.com