- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04913779
Safety and Effectiveness of an Immunobiological Drug in CoViD-19 (INPB001)
Study to Evaluate the Safety and Effectiveness of an Immunobiological Drug (Anti SARS-CoV-2) in the Treatment of Coronavirus Disease 2019 (CoViD-19)
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Vaihe
- Vaihe 2
- Vaihe 3
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Guillermo A Keller, MD PhD
- Puhelinnumero: 011-4961-0943
- Sähköposti: gkeller@anlis.gob.ar
Tutki yhteystietojen varmuuskopiointi
- Nimi: Claudio Bonel, PhD
- Puhelinnumero: 011-4303-1801
- Sähköposti: cbonel@anlis.gob.ar
Opiskelupaikat
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Ciudad Autónoma De Buenos Aires, Argentiina, 1408
- Rekrytointi
- Hospital General de Agudos Donación Francisco J. Santojanni
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Ottaa yhteyttä:
- Guillermo A Keller, MD PhD
- Puhelinnumero: 01149610943
- Sähköposti: gkeller@anlis.gob.ar
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Ottaa yhteyttä:
- Claudio Bonel, PhD
- Puhelinnumero: 011-4303-2492
- Sähköposti: cbonel@anlis.gob.ar
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Päätutkija:
- Guillermo A Keller, MD PhD
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Alatutkija:
- Guillermo Di Girolamo, MD PhD
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Active Comparator: Anti-SARS-CoV-2
Administration 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-).
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Purified F(ab')2 Fragments of Equine hyperimmune Serum with anti-SARS-CoV-2 neutralizing activity (titer 1/5120 or higher)
Muut nimet:
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Placebo Comparator: Placebo
Administration 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-).
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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-).
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change in time needed to clinical improvement
Aikaikkuna: Reached each day between day 1 and 28 post-inclusion in the study
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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).
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Reached each day between day 1 and 28 post-inclusion in the study
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change in the number of patients in each World Health Organization (WHO) Ordinal Scale Category (0 to 8 being 0 better and 8 worse)
Aikaikkuna: days 7, 14 and 21 post-inclusion
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(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);
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days 7, 14 and 21 post-inclusion
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Change in Mortality rate
Aikaikkuna: 28 days post-inclusion
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(b) Change of all-cause mortality at day 28 (OUTCOME - Efficacy);
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28 days post-inclusion
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Change in Mechanical Ventilation Requirement rate
Aikaikkuna: 28 days post-inclusion
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(c) Determination of the frequency of invasive mechanical ventilation in the total analysis period (OUTCOME - Efficacy);
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28 days post-inclusion
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Change in duration of oxygen treatment requirement
Aikaikkuna: 28 days post-inclusion
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(d) Change of the duration of oxygen therapy quantified in days of oxygen therapy (OUTCOME - Efficacy);
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28 days post-inclusion
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Change in Length of Hospitalization
Aikaikkuna: 28 days post-inclusion
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(e) Change of hospital length of hospitalization, quantified in days from study inclusion until hospital discharge (OUTCOME - Efficacy);
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28 days post-inclusion
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Change in frequency of nosocomial infection
Aikaikkuna: 28 days post-inclusion
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(F) Change in the frequency of patients with nosocomial infection (OUTCOME - Efficacy);
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28 days post-inclusion
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Change in Lymphocyte cell count
Aikaikkuna: 28 days post-inclusion
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(g) Change of absolute lymphocyte count (OUTCOME - Efficacy);
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28 days post-inclusion
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Change in viral RNA Negativization rate on nasopharyngeal swab test
Aikaikkuna: 7, 14, 21, and 28 days post-inclusion
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(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);
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7, 14, 21, and 28 days post-inclusion
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Description of adverse events type and frequency
Aikaikkuna: 28 days post-inclusion
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(i) description of reported adverse events, discriminated by their severity, and classified according to MedDRA (OUTCOME - Safety).
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28 days post-inclusion
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Requirement of additional treatments for Adverse Drug reactions
Aikaikkuna: 28 days post-inclusion
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(j) The number of subjects who required additional treatment as a consequence of reported adverse events in each therapeutic branch (OUTCOME - Safety)
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28 days post-inclusion
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Describe the AUC of purified F(ab')2 Anti-SARS-CoV-2
Aikaikkuna: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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(k1) Describe area under the curve (AUC) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients
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Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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Describe the Cmax of purified F(ab')2 Anti-SARS-CoV-2
Aikaikkuna: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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(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).
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Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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Describe the t1/2 of purified F(ab')2 Anti-SARS-CoV-2
Aikaikkuna: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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(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).
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Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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Describe the Ke of purified F(ab')2 Anti-SARS-CoV-2
Aikaikkuna: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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(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).
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Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Guillermo A Keller, PhD, INPB - ANLIS Malbrán
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- INPB001
- PRIISA.BA 2578 (Rekisterin tunniste: PRIISA.BA)
- RENIS IS003268 (Rekisterin tunniste: RENIS)
- DI-2021-2196-APN-ANMAT#MS (Muu tunniste: Disposición ANMAT)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jaon aikakehys
IPD-jaon käyttöoikeuskriteerit
IPD-jakamista tukeva tietotyyppi
- Tutkimuspöytäkirja
- Tilastollinen analyysisuunnitelma (SAP)
- Ilmoitettu suostumuslomake (ICF)
- Kliinisen tutkimuksen raportti (CSR)
- Analyyttinen koodi
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
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