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Undersøgelse af sikkerheden, tolerabiliteten og effektiviteten af ​​NP-101 til behandling af højrisikodeltagere, der er Covid-19-positive. (BOSS-002)

23. juli 2026 opdateret af: Novatek Pharmaceuticals

Et randomiseret, dobbeltblindt, placebokontrolleret, multicenter, fase IIa/IIb-studie til evaluering af sikkerheden, tolerabiliteten og effektiviteten af ​​NP-101 til behandling af højrisikodeltagere, der er testet positive for ny coronavirus 2019.

Målet med dette kliniske forsøg er at evaluere sikkerheden, tolerabiliteten og effektiviteten af ​​NP-101 til behandling af højrisikodeltagere, der er testet positive for Covid-19. Hovedspørgsmålet, som det sigter mod at besvare er:

  • For at evaluere sikkerheden af ​​NP-101, samt etablere den maksimalt tolererede dosis hos højrisiko Covid-19-positive patienter.

Deltagerne vil [beskrive de vigtigste opgaver, deltagerne vil blive bedt om at udføre, behandlinger, de vil få og bruge kugler, hvis det er mere end 2 genstande]. Hvis der er en sammenligningsgruppe: Forskere vil sammenligne [indsæt grupper] for at se, om [indsæt effekter].

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er en fase IIa/IIb multicenter, interventionel, randomiseret, dobbeltblind, placebokontrolleret undersøgelse designet til at evaluere sikkerheden, tolerabiliteten og effektiviteten af ​​NP-101 hos ambulante højrisiko COVID-19 positive deltagere. Blindende roller: Deltagere, efterforskere og sponsor

Studiet består af to dele (fase IIa og fase IIb) og fire kohorter. Den første del af forsøget (IIa) involverer tre kohorter og er et dosiseskaleringsstudie designet til at vælge den maksimalt tolererede dosis til brug i anden del (IIb) af undersøgelsen. I dosiseskaleringsdelen (fase IIa) af forsøget (n= 60) vil kvalificerede deltagere blive tilmeldt et parallelt dosiseskaleringsdesign og randomiseret i en 3:1 [aktiv+bedste støttende behandling (BSC):placebo+BSC] forhold til en af ​​tre kohorter på hver 20 deltagere (15 aktive +BSC, 5 placebo + BSC). Kohorte 1 (15 deltagere, der tager 600 mg kapsler til en samlet daglig dosis på 3 gram NP-101 plus BSC og 5 deltagere, der tager placebo plus BSC), og kohorte 2 (15 deltagere, der tager 600 mg kapsler til en samlet daglig dosis på 4,8 g af NP-101+ BSC og 5 deltagere, der tager placebo plus BSC, vil køre samtidig, da acceptable sikkerhedsdata for 3 g dosis blev opnået i et tidligere fase II studie.

Kohorte 1 vil modtage enten 3 g total daglig dosis (TDD) af NP-101 + BSC eller Placebo+ BSC, kohorte 2 vil modtage enten 4,8 g TDD af NP-101 +BSC eller placebo + BSC) og kohorte 3 (15 deltagere tager 600 mg kapsler til en samlet daglig dosis på 6 g NP-101 + BSC og 5 deltagere, der tager placebo plus BSC.) Sikkerheden vil blive evalueret i henhold til betingelserne i den statistiske analyseplan (SAP). I den anden del af forsøget (fase IIb) vil deltagere, der er tilmeldt kohorte 4 (n= 248) blive randomiseret i forholdet 1:1 (aktiv+BSC: placebo+BSC) og vil modtage den maksimalt tolererede daglige dosis ( MTDD) som bestemt af parametrene sat af SAP og godkendt af lægemiddelovervågningsteamet.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

170

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33142
        • L&A Morales Healthcare/ Enrique Villa, MD Principal Investigator
    • Illinois
      • Berwyn, Illinois, Forenede Stater, 60402
        • Research Network America
    • Texas
      • Houston, Texas, Forenede Stater, 77074
        • Clinical Trial Network
      • Pearland, Texas, Forenede Stater, 77584
        • Pearland Family Wellness Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Udlevering af underskrevet og dateret informeret samtykkeerklæring
  2. En hvilende SpO2 på >93 % på rumluft.
  3. Erklæret villighed til at overholde alle undersøgelsesprocedurer og tilgængelighed i hele undersøgelsens varighed
  4. Mand eller kvinde på 18 år og derover med milde til moderate kliniske symptomer på Covid-19-infektion (i henhold til FDA-vejledning - se bilag 3) med symptomdebut inden for 5 dage før randomiseringsdagen
  5. Positiv COVID-19-infektion bekræftet ved RT-PCR inden for de sidste 5 dage af randomiseringsdagen
  6. En score på 2 (moderat) på minimum 1 symptom på PRO Symptom Survey på dagen for randomisering
  7. Evne til at tage oral medicin og være villig til at overholde doseringsregimet (to gange om dagen - BID i 14 dage)
  8. For kvinder med reproduktionspotentiale: negativ graviditetstest ved screening og brug af højeffektiv præventionsmetode under undersøgelsesdeltagelsen og i yderligere 4 uger efter afslutningen af ​​studiets lægemiddeladministration
  9. For mænd med reproduktionspotentiale: brug af kondomer eller andre metoder til at sikre effektiv prævention sammen med partneren under undersøgelsesdeltagelsen og i yderligere 4 uger efter afslutningen af ​​studiets lægemiddeladministration
  10. Aftale om at overholde livsstilsovervejelser (se afsnit 5.3) i hele studietiden

  11. For at blive betragtet som højrisiko, skal deltagerne have mindst én af følgende betingelser:

    • alder ≥60 år;
    • aktiv cancer
    • kronisk nyresygdom;
    • kronisk lungesygdom inklusive KOL
    • Fedme (BMI ≥30)
    • alvorlige hjertesygdomme [hjertesvigt, koronararteriesygdom eller kardiomyopatier];
    • Diabetes (type 1 eller type 2)
    • Immunkompromitteret tilstand (svækket immunsystem eller autoimmune sygdomme)
    • Kronisk leversygdom
    • Cystisk fibrose
    • HIV-infektion
    • Rygning, nuværende eller tidligere
    • Seglcellesygdom eller thalassæmi
    • Transplantation af faste organer eller blodstamceller
    • Slagtilfælde eller cerebrovaskulær sygdom

Ekskluderingskriterier:

1. Aktuel eller nylig (inden for 4 uger) behandling med kortikosteroider; dog vil inhalerede steroider, som bruges til at behandle akut eller kronisk bronkial betændelse, være tilladt 2. 3. Alvorlige Covid-19 symptomer (alvorlige pr. FDA klassificering - se bilag 3) 4. Kræver øjeblikkelig indlæggelse på hospitalet uanset årsag 5. Graviditet eller amning 6. Kendte allergiske reaktioner på komponenter af sort frøolie eller thymoquinon 7. Behandling med et andet forsøgslægemiddel eller anden undersøgelsesintervention inden for 2 uger efter undersøgelsens start og i hele undersøgelsens varighed.

8. Signifikant leversygdom (ALT/AST> 4 gange ULN); enhver laboratorieparameter >/= 4 gange ULN eller blodpladetal <100.000/µL eller neutrofile granulocyttal absolut <500/mm3 9. Anamnese med moderat til svær CKD, (dvs. ved hæmodialyse eller har en estimeret glomerulær filtrationshastighed på mindre end 45 ml /min) på tilmeldingstidspunktet 10. Deltagere med inflammatorisk tarmsygdom (såsom Crohns), der kan påvirke tarmabsorptionen af ​​NP-101 enterisk coatede kapsler.

11. Kendt ukontrolleret HIV (med en nylig virusmængde > 50 kopier/ml eller CD4<200 celler/mm3 eller kendt aktiv ukontrolleret Hepatitis B (defineret som HBsAg-positiv eller påviselig HBV DNA-virusbelastning) eller kendt aktiv Hepatitis C (defineret som påviselig HCV RNA viral load) infektion 12. Influenzadiagnose (bekræftet ved test) under screening eller inden for de foregående 14 dage 13. Enhver ukontrolleret tilstand eller diagnose, både fysisk eller psykologisk, eller fysisk undersøgelse, der udelukker deltagelse, ifølge investigator 14. Nuværende behandling med CYP2C9-substrater (se bilag 5)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Aktiv lægemiddelbehandling
Fase IIa - Dosiseskalering. 3 g-kohorte og 4,8 g-kohorte kører samtidigt, efterfulgt af en 6 g-kohorte. Indgivet i 600 g kapsler af NP-101 til en samlet daglig dosis på 3 g, 4,8 g og 6 g administreret BID. Administreret i 14 dage. Etabler MTDD fase IIB - Fortsæt studiet med MTDD som fastlagt ovenfor.
Medicin: NP-101
NP-101 er et organisk afledt, GMP fremstillet produkt dækket af IND #152687.
Andre navne:
  • TQ Formel
Placebo komparator: Placebo
Som ovenfor, undtagen doseret med matchende placebokapsler.
Andet: Placebo
Identisk placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Establishment of MTDD
Tidsramme: Fourteen days per dose (Phase IIA Only)
Number of DLTS (Dose Limiting Toxicities) in the NP-101 arm at each dose compared to placebo and the safety threshold. This outcome measure ONLY APPLIES TO the Phase-IIa (Dose-finding) component of the trial.
Fourteen days per dose (Phase IIA Only)
Safety and Tolerability of NP-101 vs Placebo (Phase IIa and IIb)
Tidsramme: Through Day 45
Evaluation of the number of overall adverse events, related adverse reactions, adverse events leading to discontinuation of study drug, hospitalization, or death.
Through Day 45
Time to Sustained Clinical Recovery
Tidsramme: Through Day 5

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

This outcome measure is defined as the difference of Sustained Clinical Recovery (SCR) rates on Day 5 in patients taking the MTDD of NP-101 vs Placebo.
Through Day 5

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference of Change in Log2 of Viral Load From Baseline to Day-7 Between NP-101 and Placebo
Tidsramme: Enrollment to Day-7 on study

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

With this outcome measure, we aim to compare the change in viral load and cycle threshold profiles from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. As Viral Load and Cycle Threshold values were not available on Day-14 as the RT-PCR assessment of Covid-19 was negative, we are able to provide the change only from Baseline to Day-7.
Enrollment to Day-7 on study
Difference of Change in ORF1 Gene From Baseline to Day-7 Between NP-101 and Placebo
Tidsramme: Enrollment to Day-7

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

With this outcome measure, we aim to compare the change in viral load and cycle threshold profiles from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. As Viral Load and Cycle Threshold values were not available on Day-14 as the RT-PCR assessment of Covid-19 was negative, we are able to provide the change only from Baseline to Day-7
Enrollment to Day-7
Difference in Change of E-Gene From Baseline to Day-7 Between N101 and Placebo
Tidsramme: From Enrollment to Day-7

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

With this outcome measure, we aim to compare the change in viral load and cycle threshold profiles from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. As Viral Load and Cycle Threshold values were not available on Day-14 as the RT-PCR assessment of Covid-19 was negative, we are able to provide the change only from Baseline to Day-7.
From Enrollment to Day-7
Differenc in Change of N-Gene From Baseline to Day-7 Between NP-101 and Placebo
Tidsramme: From enrollment to Day-7

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. .

With this outcome measure, we aim to compare the change in viral load and cycle threshold profiles from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. As Viral Load and Cycle Threshold values were not available on Day-14 as the RT-PCR assessment of Covid-19 was negative, we are able to provide the change only from Baseline to Day-7.
From enrollment to Day-7
RT-PCR Negative/Undetectable Rate at Day 7
Tidsramme: Days 0 to 7

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this objective, we aim to compare the percentage of RT-PCR negative/undetectable (i.e., viral clearance) on Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo
Days 0 to 7
RT-PCR Negative/Undetectable on Day-14
Tidsramme: Day 0 to Day-14

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this objective, we aim to compare the percentage of RT-PCR negative/undetectable (i.e., viral clearance) on Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo
Day 0 to Day-14
Median Time to Sustained Clinical Recovery
Tidsramme: From Day-0 to Day-28

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this aim, we compare the median days from randomization to the attainment of Sustained Clinical Recovery between NP-101 and Placebo arms
From Day-0 to Day-28
Median Day to Complete Clinical Recovery
Tidsramme: From Day-0 to Day-28

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this aim, we compare the median days from randomization to the attainment of Sustained Clinical Recovery between NP-101 and Placebo arms
From Day-0 to Day-28
Median Days to Complete Clinical Resolution
Tidsramme: From Day-0 to Day-28

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this aim, we compare the median days from randomization to the attainment of the complete clinical resolution between NP-101 and Placebo.
From Day-0 to Day-28
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
Tidsramme: From Day-0 to Day-7

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this objective, we aim to compare the change in effector immune cells, specifically CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. We have a total of 36 markers for CD4+ and CD8+ Flow cytometry markers are combinations of the following immune cell types having various immune responses singly or in combination: CD3, CD5, CD8, CD16, CD19, CD45, CCR7, and CXCR3. The flow-cytomerty markers include the immune cell types: CD3, CD4, CD8, CD16, CD19, CD45, CCR7, and CXCR3. Markers are absolute counts of cells per cubic milimeter.
From Day-0 to Day-7
Difference of the Change From Randomization to Day-7 ın the Ratio of the Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
Tidsramme: From Day-0 to Day-7

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this objective, we aim to compare the change in the ratio of CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. Both CD4+ and CD8+ are measured as absolute counts of cells per cubic milimeter.
From Day-0 to Day-7
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
Tidsramme: From Day-0 to Day-7 Cell Percentages

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this objective, we aim to compare the change in effector immune cells, specifically CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. We have a total of 36 markers for CD4+ and CD8+ Flow cytometry markers are combinations of the following immune cell types having various immune responses singly or in combination: CD3, CD5, CD8, CD16, CD19, CD45, CCR7, and CXCR3. The flow-cytomerty markers include the immune cell types: CD3, CD4, CD8, CD16, CD19, CD45, CCR7, and CXCR3. These marker entries represent the percentages of the combination of these immune cell types or their percentages in the biological sample.
From Day-0 to Day-7 Cell Percentages
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
Tidsramme: From Day*0 to Day-14

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this objective, we aim to compare the change in effector immune cells, specifically CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. We have a total of 36 markers for CD4+ and CD8+.

Flow cytometry markers are combinations of the following immune cell types having various immune responses singly or in combination: CD3, CD5, CD8, CD16, CD19, CD45, CCR7, and CXCR3. The flow-cytomerty markers include the immune cell types: CD3, CD4, CD8, CD16, CD19, CD45, CCR7, and CXCR3. Markers are absolute count of cells per cubic milimeter.
From Day*0 to Day-14
Difference of the Change From Randomization to Day-14 ın the Ratio of the Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
Tidsramme: From Day-0 to Day-14

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this objective, we aim to compare the change in the ratio of CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. Both CD4+ and CD8+ are measured as absolute counts of cells per cubic milimeter.
From Day-0 to Day-14
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
Tidsramme: From Day-0 to Day-14

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this objective, we aim to compare the change in effector immune cells, specifically CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. We have a total of 36 markers for CD4+ and CD8+.

Flow cytometry markers are combinations of the following immune cell types having various immune responses singly or in combination: CD3, CD5, CD8, CD16, CD19, CD45, CCR7, and CXCR3. The flow-cytomerty markers include the immune cell types: CD3, CD4, CD8, CD16, CD19, CD45, CCR7, and CXCR3. These Markers represent the percentages of the combination of these immune cell types or their percentages in the biological sample.
From Day-0 to Day-14
Proportion of Participants With Symptom Progression
Tidsramme: From Day-0 to Day28

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this objective, we aim to compare the rate of disease progression measured by the worsening by the Covid-19 symptoms from 'none' or 'mild' to 'moderate' or 'severe' and remaining at that level for at least two days before alleviation or resolution, or the experience of hospitalization or death due to Covid-19 symptom worsening in participants taking the MED of NP-101 versus placebo
From Day-0 to Day28
Proportion of Paticipants With Long-Covid Symptoms
Tidsramme: Day-29 to Day-45

This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.

In this objective, we aim to compare the rate of Long- Covid symptoms in participants taking the MED of NP-101 versus placebo. A patient will be classified as having experienced symptoms indicative of Long- Covid if they reported any new or ongoing mild, moderate, or severe Long- Covid symptoms captured on the daily symptom questionnaire, on any of the following days: Day 30 ± 2 days, Day 37 ± 2 days, or Day 45 ± 2 days
Day-29 to Day-45

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novatek Pharmaceuticals

Efterforskere

  • Studieleder: Ahmed Kaseb, MD, Novatek Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. februar 2023

Primær færdiggørelse (Faktiske)

9. maj 2025

Studieafslutning (Faktiske)

9. maj 2025

Datoer for studieregistrering

Først indsendt

23. marts 2023

Først indsendt, der opfyldte QC-kriterier

23. marts 2023

Først opslået (Faktiske)

27. marts 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BOSS-Covid-19-002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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