MedTrace Logo

SARS-CoV-2 Antibodies Based IVIG Therapy for COVID-19 Patients

NCT04521309 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-03-24

No results posted yet for this study

Summary

Severe and critically ill patients will be enrolled in the study (50 patients) after duly filled consent forms. Recipients shall be divided in to 5 groups with 10 patients per group to compare clinical efficacy and safety of patients in clinical phase I/phase II study. Each group shall receive particular single dose of Intravenously administered Immunoglobulins (IVIG) developed from convalescent plasma of recovered COVID-19 individual , an experimental drug along with standard treatment except for control group which will receive standard treatment only.

Conditions

Interventions

BIOLOGICAL

SARS-CoV-2 antibody based IVIG therapy

Patient groups will receive IVIG prepared from pooled convalescent plasma from recovered COVID-19 patients. This will be administered sequentially and in varying dosages, infused over a period of 12 hours, intravenously.Additionally, all treatment groups will receive same standard care as control group. Standard Care as per hospital protocol, which may include: Airway support, Anti-Viral medication, Antibiotics, Fluid Resuscitation, Hemodynamic Support, Steroids, Painkillers, Anti-Pyretics

Sponsors & Collaborators

  • Higher Education Commission (Pakistan)

    collaborator OTHER

  • Dow University of Health Sciences

    lead OTHER

Principal Investigators

  • Dr.Shaukat Ali, PhD · Dow University of Health Sciences, Principal Dow College of Biotechnology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-19
Primary Completion
2021-01-26
Completion
2021-02-08

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04521309 on ClinicalTrials.gov