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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2020/06/026222
• Date of registration: 29-06-2020
• Prospective Registration: Yes
• Primary sponsor: Virchow Biotech Private Limited
• Public title: Intravenous Immunoglobulin Therapy in the treatment of Moderate Pneumonia in COVID-19 patients
• Scientific title: A Phase II Safety and Efficacy Study on prognosis of Moderate Pneumonia in COVID-19 patients with Regular Intravenous Immunoglobulin Therapy
• Date of first enrolment: 29-06-2020
• Target sample size: 100
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44299
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Dr Aditi
• Affiliation: Virchow Biotech Private Limited

• Name: DrHemanth Nandigala
• Affiliation: Virchow Biotech Private Limited

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Intervention1: Immunoglobulin and standard of care: Dose:0.4 g/kg body weight
Frequency once in a day
Duration 5 days
Route IV route
Control Intervention1: Standard of Care: Azithromycin 500 mg once a day for 5 days
Lopinavir/ritonavir 200 mg/50 mg - two tablets every 12 h for 14 days or for seven days after becoming asymptomatic, whichever is earlier; and (ii) For patients who are unable to take medications by mouth, 400 mg lopinavir /100 mg ritonavir 5 ml suspension every 12 h for 14 days or seven days after becoming asymptomatic whichever is earlier
Piperacillin + Tazobactam 4.5 mg in 100 ml NS three times a day for 5 days
Paracetamol 1gm tablet thrice a day; Pantocid 40 mg tablet once a day

Primary Outcome(s)

Number of days to clinical improvement.

It is defined as no. of days from initiation of treatment day to discharge day on a six-category ordinal scale

Timepoint: 0-28 days

Secondary Outcome(s)

Time to clinical improvement

Number of deaths during the follow-up of 28 days (28 days mortality).

Incidence or duration of mechanical ventilation from day 0 to 28

Duration of hospitalization from day 0 to 28.

Incidence and duration of stay in ICU from day 0 to 28.

Proportion of patients with negative RT-PCR on day 14, on day 28 (or end of the study period).



Timepoint: 0-28 days

Secondary ID(s)

VB-N-IVIG-COVID-19/2020-CT2; version 2 date 20.05.2020

Source(s) of Monetary Support

Virchow Biotech Private Limited East Avenue,Plot No:319 & 320,3rd Floor,Swamy Ayappa Society,Madhapur,hyderabad, Telangana,India-500081

Ethics review

Status: Approved
Approval date: 16/06/2020
Contact:

IEC Maharaja Agrasen Hospital

Status: Approved
Approval date: 19/06/2020
Contact:

Institutional Ethics Committee, Kings George Medical University

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee GANDHI MEDICAL COLLEGE AND HOSPITAL

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, KLE University

Status: Not Approved
Approval date:
Contact:

Max Healthcare Ethics Committee

Status: Not Approved
Approval date:
Contact:

Om Sai OncoInstitutional EthicsCommittee

Results

• Date Completed: 12/09/2020