Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Immunocin α 1.6 mg: Two subcutaneous injections of 1.6 mg Tα1 TID per day for at least seven consecutive days.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Dr Rahul Pandit
iDD Research Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male females of greater than or equal to 18 years of age at the time of consent 2.Patient who can and willing to provide written Informed Consent 3.Severe Acute Respiratory Syndrome Coronavirus SARS CoV 2 infection confirmed by polymerase chain reaction PCR test any other confirmatory tests 4.If the patient presents any one of the following features respiratory distress with a respiratory rate greater than equal toâ??30 breath per min SpO2 oxygen saturation less than or equal toâ??90 percentage on room air PaO2 arterial blood oxygen partial pressure FiO2 Fraction of Inspired Oxygen less than or equal toâ??200 mmHg 1 mmHgâ??0.133 kPa Patient presents respiratory failure and requires mechanical ventilation support 5.Patient patients LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements.
Exclusion criteria
Exclusion criteria: 1 Patient who has participated in any other clinical trial of an experimental treatment for COVID-19 2 Patient with presence of any pre-existing illness that, in the opinion of the investigator, would place the patient at an unreasonably increased risk through participation in this study. 3 Patient who has participated in another trial with an investigational drug within 1 month prior to this trial. 4 Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidences of all-cause hospital mortality 2.Duration of patients admitted in ICU and use of Ventilator. 3.Duration of hospitalizationTimepoint: 1. Incidences of all-cause hospital mortality 2.Day 1 to Day 7 3.From baseline to hospital discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in Total lymphocytes count, CD4 and CD8 count 2.Change in Ferritin levels, IL-6, LDH,CRP, D-dimer 3.Change in SpO2 level 4.Evaluation of Clinical progression deterioration based on 8-point ordinal scale 5.Number of Treatment Emergent Adverse Event TEAE and Treatment Emergent Serious Adverse Event TESAE.Timepoint: 1.Baseline to Day 7 2.Baseline to Day 7 3.Baseline to Day 7 4.Screening, Day1 to Day 7 5.Day 1 to End of study | — |
Countries
India
Contacts
Public ContactDr Adarsh Shetty
Gufic Biosciences Limited
Outcome results
None listed