Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J09X- Influenza due to identified novelinfluenza A virus
Conditions
Interventions
Intervention1: Tab Pimozide 4 mg: Pimozide is a potent antagonist to amphetamine- and apomorphine-induced sterotypes in most animal species tested. At the low-doses, Pimozide is a highly selective blo
Sponsors
Dr Rahul Kunkulol
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The conversion rate from non-hospitalization to hospitalization in the study population, percentage fall in SpO2 will be evaluatedTimepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety and tolerance of the study drug will be evaluated through clinical findings, laboratory investigations, ECG and physical examination including vital signs. Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Rahul Kunkulol
PIMS-DU Loni
Outcome results
None listed