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 twice daily for seven consecutive days.
Control Intervention1: SOC alone
: 2 subcutaneous injections of 1.6 mg Tα1 twi
Sponsors
Dr Om Shrivastava
iDD Research Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male/females of >= 18 years of age at the time of consent 2.Patient who can and willing to provide written Informed Consent 3 Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test /any other confirmatory tests 4 Patient with pneumonia with no signs of severe disease 5 If the patient presents any one of the following features: -Respiratory rate of >=â??24 breath/min -SpO2 (oxygen saturation) 6.Patient/ patientâ??s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements
Exclusion criteria
Exclusion criteria: Male/females of >= 18 years of age at the time of consent 2 The patient who can and willing to provide written Informed Consent Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test /any other confirmatory tests 4. Patient with pneumonia with no signs of severe disease 5. If the patient presents any one of the following features: - Respiratory rate >= 24 breath/min to - SpO2 (oxygen saturation) >90% to 6. Patient/ patientâ??s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements The patient who has participated in another trial with an investigational drug within 1 a month prior to this trial. 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.Duration of ICU stay [from baseline to End of study (Day 7)] 2.Ventilator duration [from baseline to End of study (Day 7)] 3.Incidences of all-cause hospital mortality [ Time Frame: From date of Drug administered until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 28 days] 4.Duration of hospitalization [ from baseline to hospital discharge]Timepoint: 1.Day 1 to Day 7 2.Day 1 to Day 7 3.Day 1 to Day 28 4.Day 1 to Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Total lymphocytes count CD4 and CD8 count from baseline Change in Ferritin levels IL-6 LDH,CRP D-dimer from baseline Change in SpO2 level from baseline till the End of study (Day 7) Evaluation of Clinical progression/deterioration based on 8-point ordinal scale time frame up to 7 days on Day 1 Screening and End of study (Day 7) Number of Treatment Emergent Adverse Event TEAE and Treatment Emergent Serious Adverse Event TESAETimepoint: 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