NCT04494984

Brief Summary

This study aims to analyze the efficacy and safety of passive immunotherapy by administering an equine hyperimmune serum (INM005) against the SARS-CoV-2 receptor binding domain (RBD) to COVID-19 patients. Improvement of the clinical course 28 days after the start of treatment will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

April 20, 2026

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

July 29, 2020

Results QC Date

March 28, 2022

Last Update Submit

March 30, 2026

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Improvement in at Least Two Categories in WHO 8-point Ordinal Clinical Scale at Day 28 or Discharge

    The primary endpoint will be the proportion of patients who showed improvement 28 days after the administration of the first dose. A responding subject is defined as a subject with improvement in at least 2 categories on the 8-point World Health Organization (WHO) ordinal scale of clinical status or a subject who is discharged. The ordinal scale measures illness severity over time, the minimum value is 0 and the maximum value is 8. The higher is the score, the worse is the outcome. Detailed scale: 0 = no evidence of infection, 1. = outpatient, with no activities limitation; 2. = outpatient, with activities limitation; 3. = hospitalised with no oxygen therapy required; 4. = oxygen therapy employing a mask; 5. = non-invasive ventilation or high flow oxygen; 6. = Mechanical ventilation; 7. = mechanical ventilation and organ support (vasopressors, extracorporeal membrane oxygenation (ECMO), renal replacement therapy (RRT); 8. = Death

    Discharge or up to Day 28

Secondary Outcomes (15)

  • Pharmacokinetics (PK) Evaluation of INM005 (Cmax)

    0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

  • Pharmacokinetics (PK) Evaluation of INM005 (Clearance)

    0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

  • Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Clearance)

    0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

  • Pharmacokinetics (PK) Evaluation of INM005 (AUC0)

    0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

  • Pharmacokinetics (PK) Evaluation of INM005 (Elimination Half-time)

    0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

  • +10 more secondary outcomes

Other Outcomes (7)

  • Anti SARS-CoV-2 Antibodies Levels

    3 weeks

  • Changes in Troponin T Levels

    3 weeks

  • Changes in D-dimer Levels

    3 weeks

  • +4 more other outcomes

Study Arms (2)

Active

ACTIVE COMPARATOR

Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).

Drug: INM005

Placebo

PLACEBO COMPARATOR

Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).

Drug: Placebo

Interventions

INM005DRUG

The investigational medicinal product (IMP) dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.

Also known as: COVIFAB
Active
PlaceboDRUG

Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.

Placebo

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects of both sexes aged 18 to 79 years of age
  • SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) for virus detection
  • Patients with moderate or severe disease by NIH definition, which requires hospitalization.
  • Acceptance to participate in the study by the signature of the informed consent by a subject or their relative, if applicable
  • Be within 10 days of the onset of symptoms at the time of the Screening visit according to a case definition from the National Ministry of Health
  • Female patients of child-bearing age with negative pregnancy test

You may not qualify if:

  • Patients who have received treatment with plasma from COVID-19 convalescents.
  • Patients who are participating in other therapeutic clinical trials
  • Patients who require mechanical respiratory assistance or are hospitalized in the ICU at the time of the screening visit.
  • History of anaphylaxis, prior administration of equine serum (por example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) or allergic reaction due to contact or exposure to horses.
  • Pregnant or breastfeeding women
  • Patients who, at the doctor's discretion, are likely to die within the next 30 days due to a concomitant disease other than the study disease
  • Patients who are expected to be referred to another institution within 72 hours of enrollment, which prevents proper follow-up of that patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Hospital de Cuenca Alta

Canuelas, Buenos Aires, B1814, Argentina

Location

Hospital Prof. Dr. Bernardo A. Houssay

Florida, Buenos Aires, Argentina

Location

Instituto Medico Platense

La Plata, Buenos Aires, B1900AVG, Argentina

Location

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Location

Hospital Municipal Emilio Zerboni

San Antonio de Areco, Buenos Aires, Argentina

Location

Hospital Alta Complejidad "El Cruce" Dr. Néstor Carlos Kirchner

San Juan Bautista, Buenos Aires, Argentina

Location

Hospital Municipal Dr. Diego E. Thompson

San Martín, Buenos Aires, Argentina

Location

Hospital Provincial Neuquén "Dr. Eduardo Castro Rendón"

Neuquén, Neuquén Province, Argentina

Location

Hospital Centro de Salud Zenón J. Santillán

San Miguel de Tucumán, Tucumán Province, Argentina

Location

Sanatorio Guemes

Buenos Aires, C1180AAD, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABH, Argentina

Location

Hospital Muñiz

Buenos Aires, C1282AEN, Argentina

Location

Hospital Pirovano

Buenos Aires, C1428, Argentina

Location

Centro Gallego de Buenos Aires

Ciudad Autonoma de Buenos Aire, Argentina

Location

Clínica Adventista Belgrano

Ciudad Autonoma de Buenos Aire, Argentina

Location

Clínica Zabala

Ciudad Autonoma de Buenos Aire, Argentina

Location

Hospital Español de Buenos Aires

Ciudad Autonoma de Buenos Aire, Argentina

Location

Sanatorio Agote

Ciudad Autonoma de Buenos Aire, Argentina

Location

Sanatorio Sagrado Corazón

Ciudad Autonoma de Buenos Aire, Argentina

Location

Related Publications (3)

  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

    PMID: 34473343DERIVED

  • Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.

    PMID: 34013969DERIVED

  • Lopardo G, Belloso WH, Nannini E, Colonna M, Sanguineti S, Zylberman V, Munoz L, Dobarro M, Lebersztein G, Farina J, Vidiella G, Bertetti A, Crudo F, Alzogaray MF, Barcelona L, Teijeiro R, Lambert S, Scublinsky D, Iacono M, Stanek V, Solari R, Cruz P, Casas MM, Abusamra L, Luciardi HL, Cremona A, Caruso D, de Miguel B, Lloret SP, Millan S, Kilstein Y, Pereiro A, Sued O, Cahn P, Spatz L, Goldbaum F; INM005 Study Group. RBD-specific polyclonal F(ab )2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial. EClinicalMedicine. 2021 Apr;34:100843. doi: 10.1016/j.eclinm.2021.100843. Epub 2021 Apr 11.

    PMID: 33870149DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Limitations and Caveats

Low number of patients included in the category "severe disease" . Overall age of the population was younger than that of other series of similar studies, making this a less generalizable finding. INM005 could be tested in other clinical stages including early and critical disease.

Results Point of Contact

Title
Fernando Goldbaum, Ph.D- Scientific Director
Organization
Inmunova
fgoldbaum@inmunova.com
+54 9 11 3180-7011

Study Officials

  • Santiago Sanguineti, Ph.D.

    Inmunova S.A.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A Double-blind, Placebo-controlled, sealed-envelope based. Access to unblinded interim results will be limited to the DMC and unblinded statistician
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: This study will be an adaptive phase 2/3 investigation. First, 12 subjects will be randomly assigned to receive 1 of the 2 treatment regimens (study drug or placebo) in a 1:1 ratio. After the first 6 subjects have been enrolled and have completed 24 hours post treatment of 2nd dose, the IDMC will review the safety data and will inform whether to continue with staggered enrollment. Randomization ratio for subjects in the following stage will be 1:1. The independent data monitoring committee (IDMC) will review safety data after 12, 24, 48 and 96 patients have been enrolled in each arm. The study will then enroll a total of 121 patients in each arm. An interim analysis will be performed after 80% of recruitment has been reached (n=194). The IDMC will analyze the rate of events in the group under "standard of care".
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2020

First Posted

July 31, 2020

Study Start

July 27, 2020

Primary Completion

November 23, 2020

Study Completion

December 30, 2020

Last Updated

April 20, 2026

Results First Posted

April 20, 2026

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

AR(19)