Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Zincum muriaticum 200C: Sucrose globules premedicated with liquid potency will be administered per orally. A single dose will consist of two globules of size 40. The dosage will be six
Sponsors
Homoeocon Foundation
Eligibility
Inclusion criteria
Inclusion criteria: A subject will be considered eligible for inclusion in this study only if ALL of the following criteria apply: 1. Hospitalized patient with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) (or any other confirmatory test to diagnose SARS-CoV-2 infection if there is such change in guidelines issued time to time by the Government of India, Task Force for COVID or any other concerned authority/body assigned for this purpose) as documented by either of the following: PCR positive in sample collected PCR positive in sample collected >= 72 hours prior to randomization with documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) 2. Subject (or legally acceptable representative) understands and agrees to comply with planned study procedures and provides informed consent prior to initiation of study procedures. 3. Male or non-pregnant female adult >=18 years of age at time of enrolment. 4. Illness with Radiographic infiltrates by imaging captured during the period between date of admission to date of enrolment that is chest x-ray, CT scan, lung ultrasound. Presence of clinical features of dyspnea and or hypoxia, fever cough including Respiratory rate > 24 breaths/min OR SpO2 Requiring supplemental oxygen Requiring HFNO/NIV 5. Women of childbearing potential must agree either to abstinence or to use at least one primary form of contraception not including hormonal contraception from the time of screening till end of the study. 6. Subject (or legally acceptable representative) agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 till end of this study. 7. Subject (or legally acceptable representative) is willing to be a study participant and to accept randomization to any assigned treatment arm.
Exclusion criteria
Exclusion criteria: 1. Physician makes a decision that trial involvement is not in patientâ??s best interest, or there is any condition that does not allow the protocol to be followed safely. 2. There is anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 3. Patient already in another clinical trial of an experimental treatment for COVID-19 4. Patient has a PaO2/FiO2 ratio < 200 or is requiring IMV/ECMO at baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TTR (Time to Recovery)Timepoint: Censored at Day 28 TTR is defined as the time (in days) from randomization of study treatment (active or placebo) until Day of recovery. Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the eight category ordinal scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Alanine Transaminase (ALT)Timepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Change from baseline in Aspartate Transaminase (AST)Timepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Change from baseline in CreatinineTimepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Change from baseline in D-dimer levelsTimepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Change from baseline in Differential WBC countTimepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Change from baseline in ESRTimepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Change from baseline in HaemoglobinTimepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Change from baseline in Platelet countTimepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Change from baseline in Prothrombin Time (PT)Timepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Change from baseline in Serum Ferritin levelsTimepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Change from baseline in Total BilirubinTimepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Change from baseline in Total WBC countTimepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Change in National Early Warning Score (NEWS)Timepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Clinical status using Ordinal scaleTimepoint: Time Frame: Day 3 through Day 28 or discharge whichever is earlier;Duration of hospitalization: Measured in daysTimepoint: Time Frame: Day 0 through Day 28;Duration of NIV or HFNO use: Measured in daysTimepoint: Time Frame: Day 0 through Day 28;Incidence of IMV or ECMO useTimepoint: Time Frame: Day 0 through Day 28;Incidence of new NIV or HFNO useTimepoint: Time Frame: Day 0 through Day 28;Mean change in | — |
Countries
India
Contacts
Public ContactDr Amitvikram Habbu
Central Council for Research in Homoeopathy
Outcome results
None listed