Treatment of Covid-19 Virus Infection Clinical Trial
Official title:
An Open Label, Multicenter, Randomized, Controlled, Clinical Study to Evaluate the Efficacy and Safety of a Combination of Treatment of Reginmune Capsule and Immunofree Tablets Compared With Standard Treatment Protocol in the Treatment of Mild to Moderate COVID-19 Patients.
| Verified date | December 2020 |
| Source | Nutrin GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
While novel drug discovery and vaccine studies are time taking process, re-purposing old drugs against the COVID-2019 epidemic can help identify treatments, with known pre-clinical, pharmacokinetic, pharmacodynamic, and toxicity profiles, which can rapidly enter Phase 3 or 4 or can be used directly in clinical settings. Immunofree has many of the herbs which have been evaluated by other trials published for Covid-19 treatment. The Immunofree tablet of the test product is an Ayurvedic proprietary medicine and is a combination of polyherbal mixture. The components of this formulation are known for their anti-viral and immunomodulatory effects. Also, Reginmune, owing to its immunomodulatory effect might help in easing the symptoms and decrease the viral load.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | December 20, 2020 |
| Est. primary completion date | December 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - Gender: Either male or non-pregnant, non-lactating female aged > 18-70 - Patients with RT-PCR confirmed diagnosis of COVID-19 - Patients with mild to moderate COVID-19 infection having either one of the following criteria: oPaO2/FiO2:200-300 OR Respiratory rate ? 24/min and SaO2/SpO2 > 90% on room air - Subjects willing to give written informed consent - Subjects able to take the drug orally and comply with the study protocol - Women of child bearing potential must have a negative urine pregnancy test prior to study entry Exclusion Criteria: - Patients with persistent vomiting - Critically ill patients - P/F ratio less than 200 (moderate-severe ARDS) - Shock (Requiring Vasopressor to maintain a MAP more than 65 mm of hg or MAP below 65) - Patients with known active hepatitis, tuberculosis and definite bacterial or fungal infections - Patients with altered mental state - Patients with multiple organ failure requiring ICU monitoring and treatment - Patients with respiratory failure and requiring mechanical ventilation - Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subject's participation in the study or interferes with the interpretation of the study results. - Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus. - Patients who have received specific antiviral drugs ritonavir/lopinavir, or chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week before admission - Patient who have participated in another investigational study within 3 months prior to enrollment in this study - Investigators, study personnel, sponsor's representatives and their first-degree relatives. - Pregnant subjects |
| Country | Name | City | State |
|---|---|---|---|
| India | Lokmanya Hospital | Pune | Maharashtra |
| India | Govt Medical College and Govt General Hospital (Old RIMSGGH) | Srikakulam | Andhra Pradesh |
| India | Parul Institute of Ayurveda and Research Parul University | Vadodara | Gujrat |
| Lead Sponsor | Collaborator |
|---|---|
| PUNEET MITTAL |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time (Days) to clinical improvement from study enrollment | This includes overall time it takes for negative covid-19 results, improvement based on a customized questionnaire for fever, cough, body ache, loss of taste or smell, or other similar conditions | Day 0 - Day 10 | |
| Secondary | Proportion of participants in each group with oxygen saturation more than 94% on room air for more than 24h | Being an important part, each patient has to be monitored for oxygen saturation level, and this would help us analyze when a subject enters from Mild to moderate stage | Day 0, Day 5±1 and Day of discharge i.e Day 10±1 | |
| Secondary | Value of coagulation indicators | D Dimer levels has to be measured to study the D dimer levels of the patient as most researchers claiming covid-19 to be relative to coagulation. This study will help us identity the same. | Day 0, Day 5±1 and Day of discharge i.e Day 10±1 | |
| Secondary | Time to first negative SARS-CoV-2 PCR in NP swab | via ICMR recognized RT-PCR to identify when a patient is coronavirusfree | Day 0, Day 5±1 and Day of discharge i.e Day 10±1 | |
| Secondary | Duration of oxygen therapy | To identify how long a patient needs oxygen therapy in certain case | upto day 10+1 | |
| Secondary | Proportion of participants in each group with need for mechanical ventilation | This is considered as a part of pharmacovigilance, as how many people enters moderate to severe case, if any | upto day 10+1 | |
| Secondary | Duration of hospitalization | most mild cases that becomes asymptomatic are sent back from hospital and treated at home quarantine. this is to identify when a patient becomes asymptomatic | upto day 10+1 |