Intravenous Immunoglobulin Therapy in the treatment of Moderate Pneumonia in COVID-19 patients

Phase 2

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/06/026222
• Lead Sponsor: Virchow Biotech Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-09-12
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 103

Inclusion Criteria

Both male or female patients who signed the informed consent and aged >=18 years ;

Patients admitted with RT-PCR confirmed COVID-19 illness.

Patient with any of the following :

Fever >=36.7â?? axilla or Oral temperature >= 38.0 â??

PaO2/ FiO2: 100-300 mmHg

Respiratory Rate >24/min and SaO2 90- 93% on room air

Lung involvement confirmed with chest X-ray.

(X-ray interpretation as mentioned in ICMR guideline-bilateral opacities, not fully explained by effusions, lobar or lung collapse, or nodules)

Exclusion Criteria

Viral pneumonia with other viruses besides COVID-19

Patients are not suitable for immunoglobulin therapy.

Patients with severe pneumonia defined as : RR >= 30 times/min or oxygen saturation <= 90% in resting state or PaO2/FiO2 <= 100 mmHg or respiratory failure and mechanical ventilation are required or shock occurs or ICU monitoring with prescence of other organ failure.

Patients on either immunoglobulin or hydroxychloroquine treatment

Pregnant or lactating women or other circumstances in which the investigator determined that the patient is not suitable for the clinical trial.

Participation in other studies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified