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COVID-19 PneumoniaPhase 2/3INPB001NCT04913779

Safety and Effectiveness of an Immunobiological Drug in CoViD-19

A Phase 2/3 study testing Anti-SARS-CoV-2 in people with COVID-19 Pneumonia and COVID-19 Respiratory Infection, run by Administracion Nacional de Laboratorios e Institutos de Salud Dr. Carlos G. Malbran at 1 site in Argentina.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aims of this study is to analyze the efficacy and safety of a passive immunotherapy strategy using hyperimmune equine serum known as Anti-SARS-CoV-2 elaborated by the National Institute for the Production of Biologicals (ANLIS-Malbrán) as an addition to the standard therapeutic approach for hospitalized patients… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Anti-SARS-CoV-2
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteArgentina
Study dates
1 Jun 2021to 31 Dec 2021
Phase
Phase 2/3
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects over 18 years old and under 80 years old.
  • Positive results by RT-PCR for SARS CoV-2
  • Clinical picture compatible with respiratory compromise in the form of pneumonia attributed to COVID-19 (Stage 3, 4 or 5 according to the WHO scale), lasting up to 72 hours from the onset of symptoms to their evaluation to be incorporated into the study.
  • Patient with good disposition towards the study and that signs the informed consent.

Who cannot join

  • Patients with clinical disease corresponding to mild / asymptomatic forms (Absence of radiological infiltrate and risk factors, with normal auscultation and arterial saturation of oxygen (SatO2) greater than 95%)
  • Patients with clinical disease corresponding to severe forms (Severe pneumonia: presence of severity criteria (ATS / IDSA), one of two major or three minor criteria.)
  • Patients who have received other therapeutic strategies in the framework of an experimental study that make it difficult to evaluate the results obtained, including (but not limited to): convalescent plasma, lopinavir / ritonavir, hydroxychloroquine, and azithromycin.
  • Pregnant or lactating women.
  • Women of childbearing potential not using an effective contraceptive method (withdrawal, intrauterine device, or oral contraceptives).
  • History of severe anaphylactic reaction with the administration of equine plasma.
  • Patients with comorbidities that justify a risk of high mortality from causes independent of SARS-CoV-2 infection (eg, stage IV cancer)
  • Patient who does not consent to participate.

Trial locations and contacts

1 site in 1 country.

Guillermo A Keller, MD PhD contact

011-4961-0943

gkeller@anlis.gob.ar

Claudio Bonel, PhD contact

011-4303-1801

cbonel@anlis.gob.ar

Argentina1 site, 1 recruiting

  • Hospital General de Agudos Donación Francisco J. Santojanni

    Buenos Aires, 1408

    Guillermo A Keller, MD PhD, 01149610943, gkeller@anlis.gob.ar

    Claudio Bonel, PhD, 011-4303-2492, cbonel@anlis.gob.ar

    Recruiting

Other trials in Argentina

About this study

Official title: Study to Evaluate the Safety and Effectiveness of an Immunobiological Drug (Anti SARS-CoV-2) in the Treatment of Coronavirus Disease 2019 (CoViD-19)

The aims of this study is to analyze the efficacy and safety of a passive immunotherapy strategy using hyperimmune equine serum known as Anti-SARS-CoV-2 elaborated by the National Institute for the Production of Biologicals (ANLIS-Malbrán) as an addition to the standard therapeutic approach for hospitalized patients with COVID-19, in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection aged 18 to 80 years.

Read the detailed description

This is an adaptive phase II/III study that aims to analyze the efficacy and safety of a immunobiological drug (Anti SARS-CoV-2) in the treatment of CoViD-19. This treatment is a passive immunotherapy strategy developed as a purified F(ab')2 fraction of equine hyperimmune serum (Anti-SARS-CoV-2). The equine serum was generated from antigenic stimulation with the SARS-CoV-2 receptor binding domain (RBD) purified protein.

This type of product (equine hyperimmune serum F(ab')2) has been widely used in our country in the last 100 years with satisfactory results and an acceptable safety profile in the treatment of accidents with poisonous animals such as anti-loxosceles, anti -latrodectus, anti-scorpionic, and anti-phoneutria, anti-bothropic, anti-micrurus, and anti-crotalic sera, all developed by the National Institute of Biological Production (ANLIS-Malbrán) and distributed free of charge in public hospitals in the country .

In the present study, evaluates the effect and safety of this immunobiological treatment in patients with COVID-19 that require hospitalization.

Being tested
Anti-SARS-CoV-2, Placebo
Keywords
Anti-SARS-CoV-2, Purified F(ab')2 Fragments, Passive immunotherapy, Equine Serum
Medical subject headings
COVID-19

What participants receive

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

  • Anti-SARS-CoV-2Drug

    Also called Purified F(ab')2 Fragments of Equine hyperimmune Serum, F(ab')2 Fragments, Passive Immunotherapy, Equine F(ab')2 Fragments

    Purified F(ab')2 Fragments of Equine hyperimmune Serum with anti-SARS-CoV-2 neutralizing activity (titer 1/5120 or higher)

  • PlaceboDrug

    Also called Control Group

    Administration of 10 ml of a control-solution without neutralizing activity against SARS-CoV-2, administered in slow intravenous infusion (10 ml diluted in 100 ml of saline solution, administered over 50 to 60 minutes in slow drip), produced by ANLIS-Malbrán, administered twice (time 0 when incorporated into the study -initial dose- and at 48 hours -second dose-).

Study groups in NCT04913779
Study groupRoleWhat they receive
Anti-SARS-CoV-2Active comparatorAdministration of 10 ml of a concentrated equine hyperimmune serum solution with neutralizing activity of SARS-CoV-2 not less than1/5120, administered in slow intravenous infusion (10 ml diluted in100 ml of physiological solution, administered over 50 to 60 minutes in slow drip), produced by ANLIS-Malbrán, administered twice (time 0 when incorporated into the study -initial dose- and at 48 hours -second dose-).
Receives: Drug: Anti-SARS-CoV-2
PlaceboPlacebo comparatorAdministration of 10 ml of a control-solution with no-neutralizing activity of SARS-CoV-2, administered in slow intravenous infusion (10ml diluted in 100 ml of physiological solution, administered over 50 to60 minutes in slow drip), produced by ANLIS-Malbrán, administered twice (time 0when incorporated into the study -initial dose- and at 48 hours -second dose-).
Receives: Drug: Placebo

What is being measured

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

  1. Change in time needed to clinical improvement

    In subjects admitted to the general ward for active infection by SARS-CoV-2 and a clinical picture of pneumonia who receive supportive treatment recommended by the guidelines of the Ministry of Health of the Argentine Nation (Population), if slow intravenous administration of Anti SARS-CoV-2 in two doses 48 hours apart (Intervention) added to supportive treatment, compared to supportive treatment alone (patients will receive slow intravenous administration of a placebo solution in two doses 48 hours apart to maintain the "blind" as Comparator), changes the time needed to clinical improvement (Outcome), during 28 days after the assignment (Time).

    Measured: Reached each day between day 1 and 28 post-inclusion in the study

Secondary outcomes (14)

  1. Change in the number of patients in each World Health Organization (WHO) Ordinal Scale Category (0 to 8 being 0 better and 8 worse)

    (a) Change in the number of patients in each World Health Organization Ordinal Scale Category (0 to 8 being 0 better and 8 worse), expecting a lower proportion of patients in categories 4, 5, 6, and 7 (OUTCOME - Efficacy);

    Measured: days 7, 14 and 21 post-inclusion

  2. Change in Mortality rate

    (b) Change of all-cause mortality at day 28 (OUTCOME - Efficacy);

    Measured: 28 days post-inclusion

  3. Change in Mechanical Ventilation Requirement rate

    (c) Determination of the frequency of invasive mechanical ventilation in the total analysis period (OUTCOME - Efficacy);

    Measured: 28 days post-inclusion

  4. Change in duration of oxygen treatment requirement

    (d) Change of the duration of oxygen therapy quantified in days of oxygen therapy (OUTCOME - Efficacy);

    Measured: 28 days post-inclusion

  5. Change in Length of Hospitalization

    (e) Change of hospital length of hospitalization, quantified in days from study inclusion until hospital discharge (OUTCOME - Efficacy);

    Measured: 28 days post-inclusion

  6. Change in frequency of nosocomial infection

    (F) Change in the frequency of patients with nosocomial infection (OUTCOME - Efficacy);

    Measured: 28 days post-inclusion

  7. Change in Lymphocyte cell count

    (g) Change of absolute lymphocyte count (OUTCOME - Efficacy);

    Measured: 28 days post-inclusion

  8. Change in viral RNA Negativization rate on nasopharyngeal swab test

    (h) change in the proportion of patients with detected viral RNA and the viral RNA load, measured by quantitative reverse transcriptase polymerase chain reaction (RT-PCR), on day 7, 14, 21, and 28 (OUTCOME - Efficacy);

    Measured: 7, 14, 21, and 28 days post-inclusion

  9. Description of adverse events type and frequency

    (i) description of reported adverse events, discriminated by their severity, and classified according to MedDRA (OUTCOME - Safety).

    Measured: 28 days post-inclusion

  10. Requirement of additional treatments for Adverse Drug reactions

    (j) The number of subjects who required additional treatment as a consequence of reported adverse events in each therapeutic branch (OUTCOME - Safety)

    Measured: 28 days post-inclusion

  11. Describe the AUC of purified F(ab')2 Anti-SARS-CoV-2

    (k1) Describe area under the curve (AUC) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients

    Measured: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days

  12. Describe the Cmax of purified F(ab')2 Anti-SARS-CoV-2

    (k2) Describe maximum plasma concentration (Cmax) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients (at time Minute 0 min, hours 1, 3, 6, 24, 48, 49 and 96, day 7, 14, 21 and 28 days).

    Measured: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days

  13. Describe the t1/2 of purified F(ab')2 Anti-SARS-CoV-2

    (k3) Describe plasma half life (t1/2) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients (at time Minute 0 min, hours 1, 3, 6, 24, 48, 49 and 96, day 7, 14, 21 and 28 days).

    Measured: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days

  14. Describe the Ke of purified F(ab')2 Anti-SARS-CoV-2

    (k4) Describe elimination constant (Ke) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients (at time Minute 0 min, hours 1, 3, 6, 24, 48, 49 and 96, day 7, 14, 21 and 28 days).

    Measured: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days

Timeline

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

  1. First posted4 Jun 2021
  2. Study start1 Jun 2021
  3. Primary completion30 Nov 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is an adaptive phase 2/3, randomized, blinded, placebo-controlled study. 200 total patients (ratio 1:1) will be included with intermediate evaluations when reaching the initial 20 patients (initial analysis of safety and pharmacokinetics), 100 (analysis of safety and efficacy) and 200 (final analysis).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04913779
Sponsor's protocol ID
INPB001
Other IDs
PRIISA.BA 2578, RENIS IS003268, DI-2021-2196-APN-ANMAT#MS
Acronym
INPB001
Status last verified
Sep 2021
First submitted
1 Jun 2021
Last updated
17 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Publication of the results of all data obtained is planned.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Anti-SARS-CoV-2 in people with COVID-19 Pneumonia and COVID-19 Respiratory Infection, run by Administracion Nacional de Laboratorios e Institutos de Salud Dr. Carlos G. Malbran at 1 site in Argentina.

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 4 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: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Guillermo A Keller, MD PhD (011-4961-0943, gkeller@anlis.gob.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in time needed to clinical improvement (time frame: Reached each day between day 1 and 28 post-inclusion in the study). 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 NCT04913779.

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 17 Sep 2021.

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