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Covid19Phase 2SECR-01NCT04610502

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

A Phase 2 study testing Administration of Equine immunoglobulin anti SARS-CoV-2 in people with Covid19, run by Caja Costarricense de Seguro Social at 4 sites in Costa Rica.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Administration of Equine immunoglobulin anti SARS-CoV-2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
4 sitesCosta Rica
Study dates
6 Sep 2020to 6 Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

Costa Rica4 sites

  • Centro Especializado de Atención COVID19 (CEACO)

    San José

  • Hospital Dr. Rafael Ángel Calderón Guardia

    San José

  • Hospital México

    San José

  • Hospital San Juan de Dios

    San José

Other trials in Costa Rica

About this study

Official 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

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.

Read more

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.

Conditions
Covid19
Being tested
Administration of Equine immunoglobulin anti SARS-CoV-2
Keywords
COVID-19, Anti-SARS-CoV-2 Equine Immunoglobulin, Passive Immunotherapy, Neutralizing Equine Antibodies.
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Administration of Equine immunoglobulin anti SARS-CoV-2Biological

    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.

Study groups in NCT04610502
Study groupRoleWhat they receive
Equine immunoglobulin anti SARS-CoV-2 formulation SExperimentalExperimental equine Imunoglobulins antiSARSCov" Formuation S
Receives: Biological: Administration of Equine immunoglobulin anti SARS-CoV-2
Equine immunoglobulin anti SARS-CoV-2 formulation MExperimentalExperimental equine Imunoglobulins antiSARSCov" Formuation M
Receives: Biological: Administration of Equine immunoglobulin anti SARS-CoV-2

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 2,3,4,5,7,10,14 Days

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

    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.

    Measured: 3 months

Secondary outcomes (11)

  1. Viral load

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

    Measured: Days 2,3,4,5,7,10,14

  2. Mortality

    Change in mortality between the two treatment groups.

    Measured: days 14, 24

  3. Hospital stay

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

    Measured: Day 14, 24

  4. ventilatory support

    Change in duration of ventilation support in the two treatment groups

    Measured: Day 24

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

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

    Measured: Days 2,3,4,5,7,10,14

  6. inflammatory markers

    Rate of virologic clearance by nasopharyngeal swab at day 10

    Measured: day 10

  7. thrombotic marker levels

    1. 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

    Measured: days 2, 3, 4, 7, 10, and 14

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

    1. 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

    Measured: 1 month

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

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

    Measured: Days 2,3,4,5,7,10,14

  10. Lung Ultrasound

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

    Measured: days 3,10

  11. Adverse events

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2020
  2. Study start6 Sep 2020
  3. Primary completion6 Oct 2020
  4. Study completion6 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04610502
Sponsor's protocol ID
R020-SABI-00259
Acronym
SECR-01
Status last verified
Mar 2021
First submitted
15 Sep 2020
Last updated
19 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Administration of Equine immunoglobulin anti SARS-CoV-2 in people with Covid19, run by Caja Costarricense de Seguro Social at 4 sites in Costa Rica.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04610502.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.

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