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NCT04521309
SARS-CoV-2 Antibodies Based IVIG Therapy for COVID-19 Patients
Phase 1, PHASE2 trial testing SARS-CoV-2 antibody based IVIG therapy in COVID-19 in 50 participants. Completed in 8 February 2021.
26 January 2021
Quick facts
| Lead sponsor | Dow University of Health Sciences |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 19 June 2020 |
| Primary completion | 26 January 2021 |
| Estimated completion | 8 February 2021 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- SARS-CoV-2 antibody based IVIG therapy — full drug profile →
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
Dow University of Health Sciences
Who can join
18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
Piechotta V, Iannizzi C, Chai KL, Valk SJ, et al · · 2021 · cited 106× · PMID 34013969 · DOI 10.1002/14651858.cd013600.pub4 -
The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1 -
Immunobiology and immunotherapy of COVID-19: A clinically updated overview.
Esmaeilzadeh A, Elahi R. · · 2021 · cited 59× · PMID 33022076 · DOI 10.1002/jcp.30076 -
Hyperimmune anti-COVID-19 IVIG (C-IVIG) treatment in severe and critical COVID-19 patients: A phase I/II randomized control trial.
Ali S, Uddin SM, Shalim E, Sayeed MA, et al · · 2021 · cited 44× · PMID 34109306 · DOI 10.1016/j.eclinm.2021.100926 -
Production of hyperimmune anti-SARS-CoV-2 intravenous immunoglobulin from pooled COVID-19 convalescent plasma.
Ali S, Uddin SM, Ali A, Anjum F, et al · · 2021 · cited 27× · PMID 33557591 · DOI 10.2217/imt-2020-0263 -
Convalescent plasma for people with COVID-19: a living systematic review.
Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 24× · PMID 36734509 · DOI 10.1002/14651858.cd013600.pub5 -
Immunotherapies and immunomodulatory approaches in clinical trials - a mini review.
Iqbal Yatoo M, Hamid Z, Rather I, Nazir QUA, et al · · 2021 · cited 23× · PMID 33577374 · DOI 10.1080/21645515.2020.1871295 -
Convalescent plasma for people with COVID-19: a living systematic review.
Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 21× · PMID 37162745 · DOI 10.1002/14651858.cd013600.pub6
Verify or expand the search:
- PubMed search for NCT04521309
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Dow University of Health Sciences trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04521309 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dow University of Health Sciences
- Last refreshed: 24 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04521309.
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