COVID-19Phase 2/3NCT04494984
A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19.
A Phase 2/3 study testing INM005 in people with COVID-19, run by Inmunova S.A. at 19 sites in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- COVID-19
- What is being tested?
- INM005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 19 sitesArgentina
- Study dates
- 27 Jul 2020to 30 Dec 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Argentina19 sites
Sanatorio Guemes
Buenos Aires, C1180AAD
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABH
Hospital Muñiz
Buenos Aires, C1282AEN
Hospital Pirovano
Buenos Aires, C1428
Hospital de Cuenca Alta
Canuelas, Buenos Aires, B1814
Centro Gallego de Buenos Aires
Ciudad Autonoma de Buenos Aire
Clínica Adventista Belgrano
Ciudad Autonoma de Buenos Aire
Clínica Zabala
Ciudad Autonoma de Buenos Aire
Hospital Español de Buenos Aires
Ciudad Autonoma de Buenos Aire
Sanatorio Agote
Ciudad Autonoma de Buenos Aire
Sanatorio Sagrado Corazón
Ciudad Autonoma de Buenos Aire
Hospital Prof. Dr. Bernardo A. Houssay
Florida, Buenos Aires
Instituto Medico Platense
La Plata, Buenos Aires, B1900AVG
Hospital Italiano de La Plata
La Plata, Buenos Aires
Hospital Provincial Neuquén "Dr. Eduardo Castro Rendón"
Neuquén, Neuquén Province
Hospital Municipal Emilio Zerboni
San Antonio de Areco, Buenos Aires
Hospital Alta Complejidad "El Cruce" Dr. Néstor Carlos Kirchner
San Juan Bautista, Buenos Aires
Hospital Municipal Dr. Diego E. Thompson
San Martín, Buenos Aires
Hospital Centro de Salud Zenón J. Santillán
San Miguel de Tucumán, Tucumán Province
About this study
Official title: A Phase 2/3, Adaptive, Randomized, Controlled, Double-blind Study to Investigate the Pharmacokinetics, Efficacy and Safety of the Hyperimmune Equine Serum (INM005) in Adult Patients With Moderate to Severe Confirmed SARS-CoV-2 Disease.
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.
Read the detailed description
The pandemic caused by the new coronavirus has generated a situation unprecedented in recent history, with several million infected and hundreds of thousands of deaths. This disease is easily transmissible by air. Although a high percentage of cases present mild clinical presentation, approximately 15% of patients present moderate to severe cases and 5% require critical care, with respiratory assistance and a high risk of mortality. No effective therapies for the treatment or prevention of SARS-CoV-2 have been identified yet. Preliminary evidence indicates that passive immunotherapy with convalescent plasma could alter the clinical course of this infection in a favorable manner. This strategy, even if confirmed as successful, requires voluntary donation by patients who have recovered, not all of whom are eligible as donors, since the antibody response varies in magnitude in different patients. This adaptive stage II/III study aims to analyze the efficacy and safety of passive immunotherapy by administering a purified Fab fraction of equine hyperimmune serum (INM005) generated from antigenic stimulation with the SARS-CoV-2 RBD protein, with the objective of neutralizing the interaction of SARS-CoV-2 with its cellular receptor, thus preventing the multiplication of the virus. The safety of this type of equine hyperimmune sera has already been demonstrated in previous and ongoing protocols with a biologically equivalent product against the E. Coli shiga toxin to treat patients with Hemolytic Uremic Syndrome (CT-INM004-01 and CT-INM004-02). In the present study, eligible patients will with moderate to severe symptoms of COVID-19 that require hospitalization will receive two 4 mg/kg doses of INM005, two days apart, with the aim of improving the clinical course of COVID-19 28 days after the start of treatment with the study drug.
- Conditions
- COVID-19
- Being tested
- INM005, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INM005Drug
Also called COVIFAB
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
- = outpatient, with no activities limitation;
- = outpatient, with activities limitation;
- = hospitalised with no oxygen therapy required;
- = oxygen therapy employing a mask;
- = non-invasive ventilation or high flow oxygen;
- = Mechanical ventilation;
- = mechanical ventilation and organ support (vasopressors, extracorporeal membrane oxygenation (ECMO), renal replacement therapy (RRT);
- = Death
Measured: Discharge or up to Day 28
Secondary outcomes (15)
Pharmacokinetics (PK) Evaluation of INM005 (Cmax)
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:
- Cmax after (mg/L) Dose 1
- Cmax (mg/L) after Dose 2
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (Clearance)
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:
- Clearance (mL/h) after Dose 1
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Clearance)
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:
- Weight-adjusted Clearance (mL/h/kg) after Dose 1
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (AUC0)
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:
- AUC0-t (mg/L*h) after Dose 1
- AUC0-I (mg/L*h) after Dose 1
- AUC0-I (mg/L*h) -Normalized- after Dose 1
- AUC0-t (mg/L*h) after Dose 2
- AUC0-I (mg/L*h) after Dose 2
- AUC0-I (mg/L*h) -Normalized- after Dose 2
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (Elimination Half-time)
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:
- Elimination half-time (hs) after Dose 1
- Elimination half-time (hs) after Dose 2
- Mean Residence Time (hs) after Dose 1
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (Elimination Rate)
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:
- Elimination rate after Dose 1
- Elimination rate after Dose 2
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (Distribution Volume)
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:
- Distribution Volume (L) after Dose 1
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Distribution Volumen)
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:
- Weight-adjusted Distribution volumen (L/kg) after Dose 1
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Time to Progression of Disease
Time to achieve decrease in at least 2 categories on the 8-point WHO ordinal scale of clinical status.
Time to discharge (days).
Time to intensive care unit (ICU) discharge (days).
Measured: 28 days
Clinical Improvement at Day 7 and Day 14
Percentage of patients who present a decrease in at least 2 categories on the 8-point WHO ordinal scale of clinical status at 7 and 14 days after the start of the treatment.
Measured: up to 2 weeks
Patients Discharged at 28 Days
Rate of discharged patients at 28 days
Measured: up to 4 weeks
Participants Who Require (ICU) Hospitalization
Cumulative percentage of patients who require Intensive care unit (ICU) hospitalization
Measured: up to 4 weeks
Participants Who Require Mechanical Ventilation Assistance (MVA)
Rate of participants who require Mechanical ventilation assistance
Measured: up to 4 weeks
Mortality at Day 28
Mortality rate due to complications from COVID-19 at day 28
Measured: up to 4 weeks
Changes in Viral Load
Percentage of participants with detectable viral load at baseline, day 7 and day 21 after the start of the treatment..
GeneFinder ™ COVID-19 PLUS RealAmp Kit was used for detection of COVID-19 virus through reverse Transcription and Real-Time Polymerase Chain Reaction from RNA extracted from Respiratory specimens such as throat swab.
This product can qualitatively detect COVID-19 using One-Step Reverse Transcription Real-Time polymerase chain reaction to confirm the presence of SARS-COV-2 by amplification of the genes RdRp (RNA-dependent RNA polymerase), E (Envelope) and N (Nucleocapsid).
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start27 Jul 2020
- Primary completion23 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Model description
- 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".
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmunova S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Santiago Sanguineti, Ph.D., Study director, Inmunova S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494984
- Sponsor's protocol ID
- CT-INM005-01
- Status last verified
- Apr 2024
- First submitted
- 29 Jul 2020
- Last updated
- 20 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34473343Piechotta 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.
PubMed 34013969Lopardo 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.
PubMed 33870149
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Adaptive, Randomized, Controlled, Double-blind Study to Investigate the Pharmacokinetics, Efficacy and Safety of the Hyperimmune Equine Serum (INM005) in Adult Patients With Moderate to Severe Confirmed SARS-CoV-2 Disease.
- ClinicalTrials.gov ID
- NCT04494984
- Acronym / sponsor ID
- CT-INM005-01
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Inmunova S.A.University, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Posted 20 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The pandemic caused by the new coronavirus has generated a situation unprecedented in recent history, with several million infected and hundreds of thousands of deaths. This disease is easily transmissible by air. Although a high percentage of cases present mild clinical presentation, approximately 15% of patients present moderate to severe cases and 5% require critical care, with respiratory assistance and a high risk of mortality. No effective therapies for the treatment or prevention of SARS-CoV-2 have been identified yet. Preliminary evidence indicates that passive immunotherapy with convalescent plasma could alter the clinical course of this infection in a favorable manner. This strategy, even if confirmed as successful, requires voluntary donation by patients who have recovered, not all of whom are eligible as donors, since the antibody response varies in magnitude in different patients. This adaptive stage II/III study aims to analyze the efficacy and safety of passive immunotherapy by administering a purified Fab fraction of equine hyperimmune serum (INM005) generated from antigenic stimulation with the SARS-CoV-2 RBD protein, with the objective of neutralizing the interaction of SARS-CoV-2 with its cellular receptor, thus preventing the multiplication of the virus. The safety of this type of equine hyperimmune sera has already been demonstrated in previous and ongoing protocols with a biologically equivalent product against the E. Coli shiga toxin to treat patients with Hemolytic Uremic Syndrome (CT-INM004-01 and CT-INM004-02). In the present study, eligible patients will with moderate to severe symptoms of COVID-19 that require hospitalization will receive two 4 mg/kg doses of INM005, two days apart, with the aim of improving the clinical course of COVID-19 28 days after the start of treatment with the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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".
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: INM005Subjects 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). |
| Placebo | Placebo comparator | Drug: PlaceboSubjects 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). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INM005Also: COVIFABThe 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. | Drug | Active |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
Number of Participants With Improvement in at Least Two Categories in WHO 8-point Ordinal Clinical Scale at Day 28 or Discharge
Time frame: Discharge or up to Day 28
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
15 secondary outcomes
Pharmacokinetics (PK) Evaluation of INM005 (Cmax)
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (Clearance)
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Clearance)
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (AUC0)
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (Elimination Half-time)
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (Elimination Rate)
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (Distribution Volume)
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Distribution Volumen)
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Time to Progression of Disease
Time frame: 28 days
Clinical Improvement at Day 7 and Day 14
Time frame: up to 2 weeks
Patients Discharged at 28 Days
Time frame: up to 4 weeks
Participants Who Require (ICU) Hospitalization
Time frame: up to 4 weeks
Participants Who Require Mechanical Ventilation Assistance (MVA)
Time frame: up to 4 weeks
Mortality at Day 28
Time frame: up to 4 weeks
Changes in Viral Load
Time frame: up to 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34473343Kreuzberger 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.
- Derived from this study: PubMed 34013969Piechotta 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.
- Derived from this study: PubMed 33870149Lopardo 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.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Sanguineti, Ph.D. study director
Inmunova S.A.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing INM005 in people with COVID-19, run by Inmunova S.A. at 19 sites 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 6 inclusion and 7 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 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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?
Yes. Results are posted in the registry (first posted 20 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Improvement in at Least Two Categories in WHO 8-point Ordinal Clinical Scale at Day 28 or Discharge (time frame: Discharge or up to Day 28). 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 NCT04494984, which also lists 3 linked publications.
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 20 Apr 2026.