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Trial - NCT04651387


Column Value
Trial registration number NCT04651387
Full text link
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04651387

First author
Last imported at : Jan. 27, 2022, 11 a.m.
Source : ClinicalTrials.gov

Licia Iacoviello, MD, PhD

Contact
Last imported at : Jan. 27, 2022, 11 a.m.
Source : ClinicalTrials.gov

licia.iacoviello@uninsubria.it

Registration date
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-12-03

Recruitment status
Last imported at : Jan. 27, 2022, 11 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - real time pcr-approved positive covid-19 test (nasopharyngeal swabs). - both gender - age between 18 and 80 years - lack of participation in other clinical trials - covid-19 severity score ≤ 5 - hospitalized ≤48 hours. - signing informed consent and willingness of the participant to accept randomization to any assigned treatment

Exclusion criteria
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

- pregnancy and breastfeeding. - bmi ≥35 kg/m2 - severe and critical covid-19 pneumonia (covid-19 severity score > 5) - patient connected to the ventilator - sao2 less than 80% - having liver failure, chronic hepatitis, cirrhosis, and cholestatic liver diseases - any severe medical condition with a prognosis of < 6 months - alcohol and drug abuse (during the last 30 days) - history of known allergy to peanuts

Number of arms
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Neuromed IRCCS

Inclusion age min
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Jan. 27, 2022, 11 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Viral load of SARS-CoV-2

Notes
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Dec. 5, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 953, "treatment_name": "Ozonized oil (hoo)", "treatment_type": "Others non pharmacological treatment", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]