NCT04610502: SECR-01

Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients

Completed Phase 2 Last updated 19 March 2021

What this trial tests

Phase 2 trial testing Administration of Equine immunoglobulin anti SARS-CoV-2 in Covid19 in 26 participants. Completed in 6 December 2020.

Timeline

6 September 2020

Primary endpoint
6 October 2020

6 December 2020

Quick facts

Lead sponsor	Caja Costarricense de Seguro Social
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	26
Start date	6 September 2020
Primary completion	6 October 2020
Estimated completion	6 December 2020
Sites	4 locations across Costa Rica

Drugs / interventions tested

• Administration of Equine immunoglobulin anti SARS-CoV-2 — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Caja Costarricense de Seguro Social — full company profile →

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Reports of the use of plasma from convalescent patients and purified immunoglobulin preparations in respiratory infections by various viral agents and SARS-CoV-2 in severely ill patients suggest that specific neutralizing antibodies may benefit their clinical course. During the previous SARS-CoV epidemic in 2003, preparations of hyperimmune equine serum were produced and demonstrated in vitro viral neutralization. These preparations were also successful in several animal models. Taking advantage of the important trajectory of our country in the study and use of equine hyperimmune serums with neutralizing antibodies for snake venom, preparations of hyperimmune serums against recombinant proteins of SARS-CoV-2 were produced through repeated immunization of horses, a first group of animals was inoculated with the "S" (Spike) protein of the virus and the second group with a mixture "M" of the S1 (Spike) proteins, the N (Nucleoprotein) protein and a construct with epitopes of the S1, E (Envelope) and M (Membrane) proteins, generating two different pharmaceutical preparations.

Objective: Evaluate the efficacy and safety of two hyperimmune equine serum anti-Sars-CoV-2 ("S" and "M") formulations as an addition to the standard therapeutic approach for hospitalized patients with COVID-19 over 18 years of age with the presence of at least 2 risk factors and a symptom onset period not exceeding 10 days.

A total of 52 patients will be included and randomly divided into two balanced groups. On day 1, all participants from each group will receive an intravenous infusion containing 10ml (one vial) of hyperimmune equine anti-Sars-CoV-2 serum labeled as A or B.

Patients will be evaluated clinically, general laboratory, SARS-CoV-2 serologies, SARS-CoV-2 viral load and cytokines level as well as pulmonary ultrasound. Data will be collected for both groups on Days 0 to 7, 10 and 14 or discharge after completion of treatment. The study will end for each participant on the day of discharge from the hospital.

Publications & conference data

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

1. 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
2. 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
3. Polyclonal hyper immunoglobulin: A proven treatment and prophylaxis platform for passive immunization to address existing and emerging diseases.
   Tharmalingam T, Han X, Wozniak A, Saward L. · · 2022 · cited 22× · PMID 34010089 · DOI 10.1080/21645515.2021.1886560
4. 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
5. 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
6. XAV-19, a Swine Glyco-Humanized Polyclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Domain, Targets Multiple Epitopes and Broadly Neutralizes Variants.
   Vanhove B, Marot S, So RT, Gaborit B, et al · · 2021 · cited 11× · PMID 34868003 · DOI 10.3389/fimmu.2021.761250
7. Hyperimmune immunoglobulin for people with COVID-19.
   Kimber C, Valk SJ, Chai KL, Piechotta V, et al · · 2023 · cited 10× · PMID 36700518 · DOI 10.1002/14651858.cd015167.pub2
8. Heterologous Hyperimmune Polyclonal Antibodies Against SARS-CoV-2: A Broad Coverage, Affordable, and Scalable Potential Immunotherapy for COVID-19.
   Alape-Girón A, Moreira-Soto A, Arguedas M, Brenes H, et al · · 2021 · cited 9× · PMID 34552950 · DOI 10.3389/fmed.2021.743325