Testing the efficacy and safety of a blood product COVID-19 Hyper-Immuneglobulin (Human) Solution in Participants with Active COVID-19

Phase 2

Completed

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/09/027903
• Lead Sponsor: Intas Pharmaceuticals Limited

Brief Summary

Overall Design



This is a prospective, open-label, two-arm, randomized, controlled, multi-centric trial for evaluation of efficacy and safety of COVID-19 Hyper-Immuneglobulin (Human) solution manufactured by Intas Pharmaceuticals Ltd. In participants with active COVID-19.

There will be 2 days of screening period followed by 28 days of study period (including 2 days treatment period with study intervention). Participants will be randomized in 1:1 ratio in treatment arm (T) and control arm [R]. Participant will be randomized EITHER in treatment arm to receive COVID-19 Hyper-Immuneglobulin (Human) solution, 30 mL dose on day 1 & 2 (at the same time preferably) plus standard of care OR in control arm to receive only standard of care.



Brief Summary



The purpose of this study is to compare efficacy and safety of addition of COVID-19 Hyper-Immuneglobulin (Human) solution against standard of care.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-22
• Last Update Posted: 2021-05-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1 Participant and/or legally acceptable representative must sign an ICF to participate in the study indicating that the participant understands the purpose of, and procedures required for the study as described in this protocol and is willing to and will be able to adhere to requirement of the protocol.
• 2 Participant must be 18 to 65 years of age (both inclusive), at the time of signing the informed consent.
• 3 Participants must have documented laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcription- polymerase chain reaction (RT-PCR) in any specimen, within less than 72 hours prior to randomization; 4 Participants with moderate or severe active COVID-19 (Clinical Management of COVID-19 Guidelines of MOHFW) at screening and baseline defined as a.
• Radiological evidence of pulmonary infiltrates or Clinical features such as dyspnea and/or hypoxia, fever, cough, AND b.
• SpO2 of less than 94 % on room air AND c.
• Respiratory rate of greater than or equal to 24 per minute 5 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a.
• Is not a woman of childbearing potential (WOCBP) OR b.
• Is a WOCBP and using an acceptable contraceptive method as described in Appendix 10.4 during the intervention period and at a minimum 30 days until after the last dose of study intervention.
• The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test [serum] within 4 days before the first dose of study intervention.
• Additional requirements for pregnancy testing during and after study intervention are in Appendix 10.2 e.
• The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
• 6 Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: a.
• Must agree not to donate sperm for the purpose of reproduction PLUS b.
• Must agree to use contraception /barrier as detailed below i.
• a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person ii.
• Should also be advised of the benefit for a female partner to use a highly effective method of contraception described in Appendix 10.4 as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.

Exclusion Criteria

• 1 Participant requiring invasive ventilation or having hemodynamic instability (MOHFW guideline) or multiple organ dysfunction/failure or evidence of bacterial superinfection (as defined by Procalcitonin level greater than or equal to 0.5 μg/L or other applicable diagnostic parameters as per standard medical care) as per the independent clinical judgment of the Investigator at screening and /or baseline.
• 2 Documented medical history of known allergies, hypersensitivity, or intolerance to intravenous immunoglobulin or other injectable form of IgG or blood products.
• 3 Documented medical history of known IgA deficiency.
• 4 Participants with a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction.
• 5 Participants who have received any blood products within 30 days prior to randomization.
• 6 Participant with more than 5 days of COVID-19 specific hospitalization prior to the first administration of treatment at baseline.
• 7 Participants who have more than 10 days between the onset of symptoms and the day of first administration of treatment at baseline.
• 8 Pregnant or breastfeeding female participants.
• 9 Currently receiving renal replacement therapy/dialysis OR Creatinine clearance less than 50 mL/min using the Cockcroft-Gault formula.
• 10 Documented medical history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
• 11 Documented medical history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening.
• 12 Currently receiving or has received in the last 14 days, experimental immune modulators, and/or monoclonal antibody therapies 13 Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline 14 Participants who have received organ transplantation or major surgery in the past 6 months.
• 15 Participants whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal.
• 16 Co-morbid systemic illnesses (uncontrolled diabetes, uncontrolled hypertension, cardiac disease, chronic lung disease, chronic kidney disease, immune-suppression and cancer or other severe concurrent disease) which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed treatment.
• 17 Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry and have received an investigational intervention 30 days or 5 half-lives (whichever is longer) before the signing the consent.
• 18 Participation in any other clinical trial of an experimental treatment for COVID-19.
• 19 Any other clinical/social/ psychiatric condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
• 20 Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of treatment with COVID-19 Hyper-Immuneglobulin (Human) plus standard of care versus only standard of care in participants with active COVID-19	Mean change from Day 1 to Day 8 in clinical outcome of treatment with COVID-19 Hyper-Immuneglobulin (Human) as compared to the control arm as assessed by 8-point ordinal scale

Secondary Outcome Measures

Name	Time	Method
- To assess the efficacy parameters for the treatment with COVID-19 Hyper-Immuneglobulin plus std of care versus only std of care in participants with active COVID-19.	- To evaluate the antibody titers of the treatment with COVID-19 Hyper-Immuneglobulin plus std of care versus only std of care in participants with active COVID-19.

Trial Locations

Locations (10)

Adichunchanagiri Hospital & Research Centre; 🇮🇳 Mandya, KARNATAKA, India

CIMS Hospital Pvt Ltd.; 🇮🇳 Ahmadabad, GUJARAT, India

Criticare Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

GMERS Medical College & Hospital; 🇮🇳 Vadodara, GUJARAT, India

Government Medical College & Hospital, Dr. Rajesh Gosavi; 🇮🇳 Nagpur, MAHARASHTRA, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Metas Adventis Hospital; 🇮🇳 Surat, GUJARAT, India

Sir Ganga Ram Hospital; 🇮🇳 Delhi, DELHI, India

Sri Ramachandra Institute of Higher Education and Research(Deemed to be University); 🇮🇳 Chennai, TAMIL NADU, India

SRV Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Adichunchanagiri Hospital & Research Centre

🇮🇳Mandya, KARNATAKA, India

Dr Ravi Nagarajaiah

Principal investigator

9448323893

ravibn972@yahoo.com