Investigator Initiated Study to Evaluate the Effectiveness and Safety of Thymosin α-1 (Tα1) in Moderate COVID-19 Patients

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: 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 twice daily along with SOC CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: 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 OUTCOME: 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 INCLUSION CRITERIA: 1.Male/females of â?¥ 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?¥â??24 breath/min ‐SpO2 (oxygen saturation) â?¤â??94% on room air 6.Patient/ patientâ??s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements
Epistemonikos ID: 2e01729b472fd0a28850dc5e156ed7b87174a278
First added on: Nov 07, 2020