Plasma therapy (IgG) in moderate to severe COVID-19 patients

Not yet recruiting

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2021/05/033622

Lead Sponsor: Lok Nayak Hospital

Brief Summary: The study will be conducted by the Lok Nayak Hospital, New Delhi. The study subjects will be enrolled from the population of moderate to severe COVID-19 positive cases requiring BiPAP support and who are willing to be a part of the study. For the study, a total of 60moderate to severe COVID-19 positive subjects would be recruitedwhich would be further divided into two treatment arms; the first treatment arm would have 30 moderate to severe COVID-19 positive subjects which will be treated with standard treatment + Intravenous Immunoglobulin (IVIG) drug at 400mg/kg/day for 5 days and the second treatment arm would have 30 moderate to severe COVID-19 positive subjects which will be treated with the standard treatment. Only the subjects (Male or Female) who are above the age of 18 would be included for the study. The criteria for the moderate and the severe illness in COVID-19 are as:-Moderate Illness: Adolescent or adult with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 â‰¤94% (range: 90-94%) on room air, Respiratory rate more or equal to 24 breaths per minutes; Severe Illness: Adolescent or adult with clinical signs of severe Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air.

All the subjects will be excluded if they have any of the following: Known hypersensitivity to immunoglobulin, History or presence of any disorder that increases the safety risk of the patient as per investigator discretion, History of DVT, PE, thromboembolic stroke or other thrombotic events, Active participant in another research treatment study andPregnancy.

The follow-ups will be done everyday till discharge and for day 30 and day 60 follow-up it can be telephonic. RT-PCR will be done at day 14 which will be repeated if negative. Day 0 follow-up will be considered as the baseline.

Safety Assessment Labs: (Screening/ Day 0, Day 5, Day 30 EOS Visit i.e., day 60) Haematology, Biochemistry (LFT, KFT, D-dimer, CRP, LDH, Urinalysis, ABG, SpO2). Safety lab assessment needs to be done at discharge. If discharge is within 7 days of scheduled safety assessment, the scheduled assessment can be skipped.

As per the investigatorâ€™s judgement Chest X ray, CT Scans (on day 30 and day 60) would be considered.

For statistical analysis data will be entered in excel sheet and analyzed using SPSS-PC25 version. Data will be expressed in proportions and relationship to immune status will be determined with co- morbid conditions, age and gender by Chi-square test. â€˜pâ€™ less than 0.05 will be considered as statistically significant.

A proper written informed consent will be obtained from all the study participants after explaining the study procedures along with benefits and risks of participation. Participation will be on voluntary basis. Privacy and confidentiality of data will be maintained.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Male or female subjects in between 18 years to 65 years 1.Moderate Illness: Adolescent or adult with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 â‰¤94% (range: 90-94%) on room air, Respiratory rate more or equal to 24 breaths per minutes.
(As per MoHFW) 2.Severe Illness: Adolescent or adult with clinical signs of severe Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air.
(As per MoHFW).

Exclusion Criteria

Known hypersensitivity to immunoglobulin.
History or presence of any disorder that increases the safety risk of the patient as per investigator discretion.
History of DVT, PE, thromboembolic stroke or other thrombotic events.
Active participant in another research treatment study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical improvement measured by improvement in National Early Warning Score 2 (NEWS2) Score at the end of treatment	3 months

Secondary Outcome Measures

Name	Time	Method
Change in oxygen saturation by pulse oximetry. All-cause mortality till day 60	Mean Number of days of hospitalization.

Trial Locations

Locations (1): Maulana Azad Medical College
🇮🇳
Central, DELHI, India
Maulana Azad Medical College
🇮🇳Central, DELHI, India
Dr M K Daga
Principal investigator
9968604273
drmraduldaga@gmail.com