Clinical trial on Mild and Moderate COVID-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/12/038672
- Lead Sponsor
- Arna Immuno Ingredients Pvt Ltd AIP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
1.Age: 18-60 years
2.Gender: Both (Male and Female)
3.Should be classifiable into the ICMR criteria of mild-moderate COVID- 19 category. [Subjects with clinical signs of fever, cough, dyspnea, fast breathing with respiratory rate <30/min, no signs of severe pneumonia, including SpO2 �90% on room air without evidence of viral pneumonia or hypoxia]
4.Symptomatic subjects with RT-PCR/laboratory-confirmed COVID-19 cases (not more than 3 days prior to study entry, Ct value <35 cycles)
5.For subjects with a history of lung fibrosis, COPD, Smokers, long- standing asthmatics: CT-Scan does not indicate any observations of severe/critical COVID-19 condition
6.Currently not requiring hospitalization (i.e. Out-patients / Home quarantine / COVID-Care facility only)
7.Willing to undertake home quarantine/COVID-care centre for the 3 (three) weeks of the study and 2 (two) weeks of post-therapy follow-up
8.Willing to get hospitalized if worsening of COVID-19 to severe or critical occurs, on the advice of the treating physician and/or the medical monitor of the study (based on the current ICMR criteria4)
9.Agrees to provide a written or electronic copy of the signed informed consent form (ICF)
10.Agrees to follow all requirements of COVID-19 safety protocols, compliance and to any nutritional restrictions and dosing regimen (including home quarantine/hospital admission, blood for lab analysis for a minimum of 4-8 times, and complete the subject diary (temp, symptoms, signs, drug dosages and other parameters daily)
11.Has an Aadhar ID or equivalent ID proof, smartphone/mobile connectivity and is willing to receive calls and messages at least once a day by community outreach activities, such as home visits or by remote connect telemedicine by health care workers assigned to this project and authorized by this investigator.
12.Individuals who agree not to take any additional medications or other antibiotics during the study period (5-weeks from entry) other than that prescribed as part of Standard Therapy by the physician-in-charge of the study
13.Agrees not to self-medicate or take any other therapies during the study and has not been on any such medications, like ivermectin, hydroxychloroquine, dexamethasone, methylprednisolone, budeso-nide (other steroids) or other ayurvedic, homoeopathic, Siddha, or other forms of medications for the past 1 (one) week and agrees to not use during the study period over and above the standard care of therapy that is prescribed
1.Individuals who will not give written consent (wet-ink/electronic)
2.Classification of patientââ?¬•s symptoms are worse (severe, critical), or needing oxygen/ventilator support [Oxygen saturation <90% on room air, Respiratory rate >30 breaths/min, Signs of severe respiratory distress and/or pneumonia]
3.Asymptomatic individuals or COVID-19 RT-PCR negative (Ct value �35 cycles)
4.Known history of allergy or contraindications for Lf/Lc components
5.Pregnant/Lactating women
6.Individuals who do not agree to not receive or not take any additional medications or other antibiotics during the study period (5-weeks from entry) other than that prescribed as part of Standard Care Therapy by the physician-in-charge of the study
7.Individuals on any other medications or nutritional supplements that may influence Lf/Lc evaluations
8.Individuals not willing to follow protocol specified diet/nutrition guidelines
9.Known cases of uncontrolled Diabetes and Hypertension or other serious co-morbid conditions
10.Subjects with a history of severe asthma, interstitial lung disease, or chronic pneumonitis unrelated to COVID-19
11.Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening for this study
12.History of renal failure or dialysis, hypercalcemia, severe liver disease (cirrhosis), sarcoidosis, or other granulomatous diseases (Wegener)
13.Previously diagnosed cases of immune-compromised status like HIV, Hepatitis B/C, Tuberculosis, Cancer, etc. or deranged liver or kidney tests
14.Subjects taking or need to take systemic/oral steroid treatment and or any kind of immunosuppressive therapy in the pre-study within the last 30 days and during the study period
15.Subjects participating in any other clinical study or having participated in any other study <1 month prior to screening in the present study
16.Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his participation in, and completion of the protocol or their evaluation for protocol parameters
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a) Change from baseline in C-reactive protein (CRP) and D-dimer after starting treatment on Day 2, Day 3, Day 5, Day 10, Day 15, Day 21, and post-therapy on Day 28 and Day 35 (total 5 weeks) b) Change from baseline in other biomarkers after starting supplementation along with treatment based on testing schedule during the 5 week study period c) Proportion of patients� progression of COVID-19 grade from (baseline, non-hospitalized) mild-moderate to severe-critical (leading to hospitalization) at Day 5, Day 10, Day 15, and Day 21 <br/ ><br>d) Time to progress from mild-moderate (non-hospitalized) grades to severe-critical (hospitalization) grade e) Reduction in viral shedding (repeat Post-Rx quantitative RT-PCR) f) Improvements in COVID-19-related symptoms <br/ ><br>Timepoint: Day 0 Day 2, <br/ ><br>Day 3, Day <br/ ><br>5, Day 10, <br/ ><br>Day 15, Day <br/ ><br>21, and <br/ ><br>post-therapy on Day 28 <br/ ><br>and Day 35 <br/ ><br>
- Secondary Outcome Measures
Name Time Method a)Progression of signs and symptoms of COVID-19 monitored thrice daily (temp, O2 saturation,) - from the subject diary <br/ ><br>b)Pre-study and post-study levels on Day 0, Day 21 and Day 35 of the following other biomarkers: <br/ ><br>1.Serum Zn <br/ ><br>2.Serum Fe <br/ ><br>3.Serum Ca <br/ ><br>4.Ferritin <br/ ><br>5.Histamine (additionally, on Day 05) <br/ ><br>Timepoint: Day 0, Day 21 <br/ ><br>and Day 35 <br/ ><br>