Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01) (COVITOZ-01)
24 augusti 2021 uppdaterad av: Jose A Perez Molina, Hospital Universitario Ramon y Cajal
Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19
unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
National, unicenter, randomized, open-label, controlled phase II clinical trial with a drug marketed and administered under conditions of use other than those approved.
The study is designed to evaluate the effect of adding Tocilizumab to standard or standard of care for patients infected with COVID-19 and diagnosed with mild-moderate pneumonia.
78 patients are expected to be included in the study in a single center in Spain. The study includes a selection and randomization period, and a 28-day follow-up period (or until death, or premature withdrawal, whichever is earlier). Once the patients complete the study, they will continue with their usual follow-up.
Studietyp
Interventionell
Inskrivning (Faktisk)
26
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Madrid, Spanien, 28034
- Hospital Universitario Ramon y Cajal
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Patients over 18 years of age who have given their informed consent. This will be collected verbally and will be recorded in the medical record by the investigating doctor.
The patient is diagnosed with mild-moderate SARS-CoV-2 pneumonia confirmed microbiologically ≤7 days before randomization, and presents:
to. Basal oxygen saturation> 90% b. CURB-65 ≤1 c. PaO2 / FiO2≥300 or SatO2 / FiO2≥315
- The patient is hospitalized or meets hospital admission criteria.
- The patient is not expected to enter the ICU or die in the next 24 hours.
Exclusion Criteria:
- Participants in another simultaneous clinical trial.
- Use of other immunomodulators.
- Coinfection with the hepatitis B virus (detectable AgSup-HBV).
- Pregnancy (or planning to become pregnant during the course of the study), or lactation period.
- Presence of laboratory abnormalities of grade ≥ 4.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: TCZ 8 mg / kg one dose
TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment
|
Tocilizumab 20 MG/ML Intravenous (one dose)
|
|
Experimentell: TCZ 8 mg / kg in two
TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment
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Tocilizumab 20 MG/ML Intravenous ( two doses)
Andra namn:
|
|
Inget ingripande: standard care treatment
Usual / standard care treatment
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
Tidsram: Day1 and Day3.
|
Average increase in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
|
Day1 and Day3.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression of pneumonia
Tidsram: Day3, Day7 and Day28
|
Percentage of patients per group with progression of pneumonia in Day3, Day 7 and Day28
|
Day3, Day7 and Day28
|
|
PaO2/FiO2
Tidsram: Day3, Day7 and Day28
|
Proportion of patients with PaO2 / FiO2 <300 (or SatO2 / FiO2 ≤315) at some point in the evolution.
|
Day3, Day7 and Day28
|
|
cause mortality to 28 days after started treatment
Tidsram: Day3, Day7 and Day28
|
cause mortality to 28 days after started treatment
|
Day3, Day7 and Day28
|
|
Length of hospital stay
Tidsram: Day3, Day7 and Day28
|
Length of hospital stay
|
Day3, Day7 and Day28
|
|
patients requiring Intensive Care Unit admission
Tidsram: Day3, Day7 and Day28
|
Percentage of patients requiring Intensive Care Unit admission
|
Day3, Day7 and Day28
|
|
evolution of inflammatory parameters IL12
Tidsram: Day0, Day3 and Day7
|
IL-12 levels at Day 7
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Day0, Day3 and Day7
|
|
evolution of inflammatory parameters IL-10, IL-1, IL-6, IL-17 and IFN-gamma
Tidsram: Day0, Day3 and Day7
|
IL-10, IL-1, IL-6, IL-17 and IFN-gamma levels on days Day 0, Day1, Day 3 and Day 7
|
Day0, Day3 and Day7
|
|
evolution of inflammatory parameters Procalcitonin (PCT),
Tidsram: Day0, Day3 and Day7
|
Procalcitonin (PCT), levels on days Day0, Day1, Day3 and Day 7
|
Day0, Day3 and Day7
|
|
evolution of inflammatory parameters C-reactive protein (PCR),
Tidsram: Day0, Day3 and Day7
|
C-reactive protein (PCR),levels on days Day0, Day1, Day3 and Day 7
|
Day0, Day3 and Day7
|
|
evolution of inflammatory parameters D-dimer
Tidsram: Day0, Day3 and Day7
|
D-dimer levels on days Day0, Day1, Day3 and Day 7
|
Day0, Day3 and Day7
|
|
evolution of inflammatory parameters and ferritin
Tidsram: Day0, Day3 and Day7
|
ferritin levels on days Day0, Day1, Day3 and Day 7
|
Day0, Day3 and Day7
|
|
pharmacokinetics of tocilizumab Cmin
Tidsram: Day0, Day1 Day3 and Day7
|
Cmin,on Day0, Day1, Day3 and Day7.
On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
|
Day0, Day1 Day3 and Day7
|
|
pharmacokinetics of tocilizumab Cmax
Tidsram: days Day0, Day1 Day3 and Day7
|
Cmax,on Day0, Day1, Day3 and Day7.
On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
|
days Day0, Day1 Day3 and Day7
|
|
pharmacokinetics of tocilizumab Cmedia
Tidsram: days Day0, Day1 Day3 and Day7
|
Cmedia,on Day0, Day1, Day3 and Day7.
On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
|
days Day0, Day1 Day3 and Day7
|
|
pharmacokinetics of tocilizumab Tmax
Tidsram: days Day0, Day1 Day3 and Day7
|
Tmax,on Day0, Day1, Day3 and Day7.
On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
|
days Day0, Day1 Day3 and Day7
|
|
pharmacokinetics of tocilizumab AUC
Tidsram: days Day0, Day1 Day3 and Day7
|
AUC,on Day0, Day1, Day3 and Day7.
On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
|
days Day0, Day1 Day3 and Day7
|
|
Adverse event
Tidsram: days Day0, Day3, Day7 and Day28
|
Serious and non-serious adverse events.
|
days Day0, Day3, Day7 and Day28
|
|
Adverse event to cause the treatment interruption.
Tidsram: days Day0, Day3, Day7 and Day28
|
Adverse events to cause the treatment interruption.
|
days Day0, Day3, Day7 and Day28
|
|
Adverse event Abnormalities in laboratory
Tidsram: days Day0, Day3, Day7 and Day28
|
Abnormalities in laboratory findings unrelated to COVID-19 disease.
|
days Day0, Day3, Day7 and Day28
|
Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
4 maj 2020
Primärt slutförande (Faktisk)
4 november 2020
Avslutad studie (Faktisk)
10 februari 2021
Studieregistreringsdatum
Först inskickad
11 juni 2020
Först inskickad som uppfyllde QC-kriterierna
16 juni 2020
Första postat (Faktisk)
17 juni 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 augusti 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 augusti 2021
Senast verifierad
1 augusti 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- COVITOZ-01
Plan för individuella deltagardata (IPD)
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