Effect of convalescent plasma in COVID-19 patients

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 29

Inclusion Criteria

Recipient:

Severe COVID -19 infections defined as WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria-

1.Respiratory distress, RR >=30 beats/min

2.Oxygen saturation level less than 93% in resting state

3.Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) <= 300 mmHg.

4.Lung infiltrates > 50% within 24 to 48 hours

5. Very sick (on ventilator) and patients with co-morbidities such as patients with known co-

morbid diseases (COPD, CAD, CLD, CKD, cardiopulmonary disease-structural or valvular heart

disease)

6. Patient presenting with multi organ failure or requiring mechanical ventilation.

7. Minimum age: 18 yrs to maximum age- no limit as per recent protocol amendment.

Donor:

• Known case of recovered COVID-19 Infection, and

• Complete resolution of symptoms at least 28 days prior to donation or

Complete resolution of symptoms at least 14 days prior to donation and negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from the blood,

And

Negative RT-PCR for COVID-19 on two sequential paired nasopharyngeal and throat specimens > 24 hrs apart (WHO-CDC guideline).

•Donor Plasma after 2 negative tests and 2 weeks of remaining asymptomatic, without antibody titre & presence of IgG/IgM antibodies to COVID-19 by serological as per manufacturers instructions. Donors negative for these will be deferred).

• Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs & Cosmetics Act and Rules 1945, amended 11.03.2020.

Exclusion Criteria

Recipient

• Patients with age less than 18 years.

• Pregnancy

• Individual with HIV and Hepatitis

• Morbid Obesity BMI >35 kg/m2

• Extremely moribund patients with an expected life expectancy of less than

24 hours.

• Failure to give informed consent from the patient or family members.

• Hemodynamic instability requiring vasopressors.

• Previous allergic history to plasma.

Donor:

•Donors age < 18 and >=60 years old

• Do not fulfil all criteria of donor eligibility for donor Plasmapheresis under

the Drugs & Cosmetics Act and Rules 1945, amended 11.03.2020.

• Females who have been pregnant and previously transfused donors (to

prevent TRALI).

• Donors who have taken steroids during treatment for COVID-19.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients remaining free of mechanical ventilation in both groupsTimepoint: day 7

Secondary Outcome Measures

Name	Time	Method
Days free of dialysis in both groupsTimepoint: day 28;Duration of hospital Stay in both group.Timepoint: day 28;Duration of Intensive Care Unit stay in both groups.Timepoint: day 28;Improvement in Pa02/Fi02 ratio in both groupsTimepoint: day 2 and day 7;Improvement in SOFA score in both groupsTimepoint: day 2 and day 7;Mortality in both groupsTimepoint: day 28;Requirements of Vasopressor in both groups.Timepoint: day 28

Related Trials