Clinical study designed to evaluate use of Pimozide as an add on therapy in non-hospitalized patients with mild COVID-19 illness
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J09X- Influenza due to identified novelinfluenza A virus
- Registration Number
- CTRI/2022/04/041885
- Lead Sponsor
- Dr Rahul Kunkulol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Confirmed Patients of COVID 19 illness as indicated by a positive rapid antigen test or SARS-CoV-2 RT-PCR test for nasopharyngeal or oropharyngeal, sputum, or lower respiratory tract samples, onlypatients with mild severity will be included. Mild severity will be defined as Upper respiratory tract symptoms and/or fever without shortness of breath or hypoxia (SpO2 above 94% on room air)
2.Patients 18 years or older age of either gender
3.Body mass index (BMI) between 17.0 kg/m2 to 30.0 kg/m2, inclusive for Patients calculated as (weight in kg) / (height in m)2
4.Patient who understands and signs the informed consent form to participate in the study.
5.Patient who is willing to be available for the entire study period and to adhere to protocol requirements
6.Women of childbearing potential (WOCBP) or men whose partner is a WOCBP agrees to use contraception while participating in this study, and for a period of 14 days following termination of study treatment.
Contraception is defined as one of the following:
a. Surgically sterile (bilateral tubal ligation for women or vasectomy for men) OR
b. Using a condom AND one of the following:
i. Combined (estrogen-progesterone) hormonal contraception
ii. Progesterone-only hormonal contraception
iii. Intrauterine device OR
iv. Intrauterine hormone-releasing system
Note Patients that are at high risk for hospitalization including obesity, hypertension diabetes, ischemic heart disease, and older age will also be included in the study.
Exclusion Criteria
1.Pregnancy
2.Patients who have been involved in any interventional studies in the past 1 year
3.Presence of any clinically significant results from laboratory tests, vital signs assessments, and electrocardiograms, as judged by the investigator(s).
4.Patients with severe hepatic impairment on admission (alanine aminotransferase higher than fivefold the upper limit)
5.Reports a history of clinically significant allergies including food or drug allergies.
6. Patient having history of hypersensitivity to Pimozide
7.Patient with ongoing treatment of antifungal medication
8.Patients not willing to sign informed consent form
9.Difficulty in swallowing solids like tablets or capsules.
10.Actively using corticosteroids, except topical corticosteroids equivalent to or less than 1% hydrocortisone
11.Any other condition, that in the investigatorâ??s judgment, might compromise patient safety or affect study results
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The conversion rate from non-hospitalization to hospitalization in the study population, percentage fall in SpO2 will be evaluatedTimepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method The safety and tolerance of the study drug will be evaluated through clinical findings, laboratory investigations, ECG and physical examination including vital signs. <br/ ><br>Timepoint: 28 days