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NCT Number: NCT04610502

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro Especializado de Atención COVID19 (CEACO), San José, Costa Rica

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Agreement to participate in the study by signing the prior informed consent.
  • Age over 18 years.
  • Inpatient with RT-PCR confirmation of SARS-CoV-2.
  • Period of onset of symptoms related to COVID-19 not greater than 10 days
  • Presence of at least 2 documented risk factors
  • Moderate and severe clinical presentation of the disease.

Exclusion criteria

  • Patients who did not sign the Informed Consent.
  • Critical patient.
  • Patient previously bitten by a snake that was treated with equine hyperimmune serum.
  • Patients with COVID-19 on an outpatient basis.
  • Pregnant women.
  • Patients in Hemodialysis program.
  • Patients who have already received plasma from a convalescent COVID-19 patient.
  • Patients who were classified prior to the diagnosis of COVID-19 by the treating physician as having a reserved prognosis with a short lifespan.

Treatment and study plan

Administration of Equine immunoglobulin anti SARS-CoV-2

Biological

The participants will receive premedication with Acetaminophen 500mg PO, Cimetidine300mg IV and Chlortrimeton 10mg IV. Then the investigators will do the Administration of Equine Imunoglobulin anti SARS Cov 2 on day 1 a vial of 10ml of the drug during 1 hour Intravenously. Then the hospitalized participants will be followed until they are discharged.

Primary outcomes

  1. To evaluate the efficacy and safety of two formulations of equine anti-SARS-CoV-2 immunoglobulins ("S" and "M").

    Time frame: 2,3,4,5,7,10,14 Days

    Change in clinical status (days requiring supplemental oxygen) between the two treatment groups.

  2. To evaluate safety of two formulations of equine anti-SARS-CoV-2 immunoglobulins ("S" and "M").

    Time frame: 3 months

    To identify the adverse effects of anti-Sars-CoV-2 type "S" or type "M" equine immunoglobulins administered to patients diagnosed as SARS-CoV-2 positive, with the presence of at least 2 risk factors and a symptom onset period of no more than 10 days.

Secondary outcomes

  1. Viral load

    Time frame: Days 2,3,4,5,7,10,14

    Change of viral load (number of copies of SARS Cov2 per ml)

  2. Mortality

    Time frame: days 14, 24

    Change in mortality between the two treatment groups.

  3. Hospital stay

    Time frame: Day 14, 24

    Change in the overall hospital stay of patients between the two treatment groups.

  4. ventilatory support

    Time frame: Day 24

    Change in duration of ventilation support in the two treatment groups

  5. blood levels of immunoglobulins against SARS-CoV-2

    Time frame: Days 2,3,4,5,7,10,14

    Change in titer of immunoglobulins blood levels (UA/ml) against SARS-CoV-2 between the two treatment groups.

  6. inflammatory markers

    Time frame: day 10

    Rate of virologic clearance by nasopharyngeal swab at day 10

  7. thrombotic marker levels

    Time frame: days 2, 3, 4, 7, 10, and 14

    • Difference in the decrease of thrombotic marker levels (D-dimer, fibrinogen, prothrombin time, TTP) on study days 2, 3, 4, 7, 10, and 14 or at discharge between the two treatment groups

  8. negativization period of RT-PCR on nasopharyngeal swabbing (Reverse transcription polymerase chain reaction)

    Time frame: 1 month

    • Difference in the number of days elapsed between two negative determinations separated by at least 24 hours in the COVID-19 test by RT-PCR on nasopharyngeal swabbing between the two treatment groups

  9. SpFI (Partial saturation Oxigen/inspired fraction of Oxigen) gain

    Time frame: Days 2,3,4,5,7,10,14

    Improvement in SAFI (SatO2/FiO2) between the two treatment groups.

  10. Lung Ultrasound

    Time frame: days 3,10

    Change in POCUS score between the two treatment groups. (Minimum: 0 = normal; Maximum: 32= Multiple Lungs Consolidations).

  11. Adverse events

    Time frame: days 2,3,4,5,6,7,10,14,24

    Number of adverse events as measured by CTCAE v. 5.0 between the two groups

Sponsors and collaborators

Lead sponsor

Caja Costarricense de Seguro Social

Other Gov

Collaborators

  • Ministry of Health Costa Rica
  • Universidad de Costa Rica

Registry information

Official study title

Randomized, Controlled, Double-blind, Multicenter Clinical Study to Compare the Efficacy and Safety of the Administration of Two Hyperimmune Equine Anti-Sars-CoV-2 ("S" and "M") Serum Formulations in Hospitalized Patients With COVID-19

Acronym: SECR-01

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2020
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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