NCT04548557

Intravenous Immunoglobulins for the Treatment of Covid-19 Patients: a Clinical Trial

Status unknown Phase 3 Last updated 14 September 2020

What this trial tests

Phase 3 trial testing intravenous immunoglobulin therapy in Covid19 in 60 participants. Status unknown.

Timeline

15 September 2020

Primary endpoint
15 October 2020

15 November 2020

Quick facts

Lead sponsor	University of Health Sciences Lahore
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	15 September 2020
Primary completion	15 October 2020
Estimated completion	15 November 2020
Sites	1 location across Pakistan

Drugs / interventions tested

• intravenous immunoglobulin therapy — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

University of Health Sciences Lahore

Who can join

Adults 18 to 90, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The current project is based on the immunological studies covering the potential of disease induced immunoglobulins as treatment regime. We would be able to generate the concentrated antibodies specific against coronavirus (Covid-19). These antibodies can be used as serum therapy. Aside from a Covid-19 vaccine, antibodies from recovered patients could provide a short-term "passive immunization" to the disease. Those antibodies can be extracted from the blood serum of surviving patients and then injected into infected people. Passive immunization usually lasts for a few weeks or months, after which those borrowed or donated antibodies, get broken down by the host body within about 30 days. While drugs to treat patients with covid-19, and vaccines to prevent infection are being developed, a fast acting, stopgap serum therapy could be useful as a first aid for high-risk patients.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. An updated overview of recent advances, challenges, and clinical considerations of IL-6 signaling blockade in severe coronavirus disease 2019 (COVID-19).
   Elahi R, Karami P, Heidary AH, Esmaeilzadeh A. · · 2022 · cited 33× · PMID 35074571 · DOI 10.1016/j.intimp.2022.108536
2. Neurological complications associated with Covid-19; molecular mechanisms and therapeutic approaches.
   Mahboubi Mehrabani M, Karvandi MS, Maafi P, Doroudian M. · · 2022 · cited 29× · PMID 35138001 · DOI 10.1002/rmv.2334
3. The Road towards Polyclonal Anti-SARS-CoV-2 Immunoglobulins (Hyperimmune Serum) for Passive Immunization in COVID-19.
   Focosi D, Tuccori M, Franchini M. · · 2021 · cited 21× · PMID 33671893 · DOI 10.3390/life11020144
4. Recent advances in passive immunotherapies for COVID-19: The Evidence-Based approaches and clinical trials.
   Farhangnia P, Dehrouyeh S, Safdarian AR, Farahani SV, et al · · 2022 · cited 2× · PMID 35483235 · DOI 10.1016/j.intimp.2022.108786