Impact of a Monoamine Oxidase Inhibitor on the Phenotype of Blood Mononucleated Cells in Patients With COVID-19

NCT04590222 | Completed

• 2 other identifiers: APHP2009892020-A02398-31
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The principal objective is to determine the impact of phenelzine on the activation phenotype of T cells and myeloid cells during SARS-CoV2 infection

Conditions

SARS-CoV2 Infection

Keywords

SARS-CoV2 Infection; Monoamine Oxidase Inhibitor; Activation phenotype of T and myeloid cells

Outcome Measures

Primary Outcomes (1)

• levels of lymphocytes T DR + CD38 + and of monocytes CD14 dim + CD16 +.

  evaluate the levels of the activation of T cells and myeloid cells after phenelzine exposure by the levels of the % of DR+ CD38+ T cells and CD14+dim CD16+ monocytes.

  through study completion, an average of 1 year

Secondary Outcomes (5)

• level of immune checkpoints

  through study completion, an average of 1 year

• cytokine production and proliferation

  through study completion, an average of 1 year

• levels of neutrophils

  through study completion, an average of 1 year

• level of immune responses in obese patients

  through study completion, an average of 1 year

• level of immune responses for men and women

  through study completion, an average of 1 year

Study Arms (9)

Female, BMI≥30, mild

Females: Obese BMI≥30 With Mild infection n = 10

Other: blood sample

Female, BMI≥30, severe

Females: Obese BMI≥30 With severe infection n = 10

Other: blood sample

Female, BMI<30, mild

Females: Non-Obese BMI\<30 With Mild infection n = 10

Other: blood sample

Female, BMI<30, severe

Females: Non-Obese BMI\<30 With severe infection n = 10

Other: blood sample

male, BMI≥30, mild

males: Obese BMI≥30 With Mild infection n = 10

Other: blood sample

male, BMI≥30, severe

males: Obese BMI≥30 With severe infection n = 10

Other: blood sample

male, BMI<30, mild

males: Non-Obese BMI\<30 With Mild infection n = 10

Other: blood sample

male, BMI<30, severe

males: Non-Obese BMI\<30 With severe infection n = 10

Other: blood sample

Healthy donors from the EFS (Etablissement Français du Sang, St Louis)

Healthy donors from the EFS (Etablissement Français du Sang, St Louis) including 5 men and 5 women

Other: blood sample

Interventions

blood sample OTHER

One blood sample of 60 mL (EDTA)

Female, BMI<30, mild; Female, BMI<30, severe; Female, BMI≥30, mild; Female, BMI≥30, severe; Healthy donors from the EFS (Etablissement Français du Sang, St Louis); male, BMI<30, mild; male, BMI<30, severe; male, BMI≥30, mild; male, BMI≥30, severe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the Bicêtre Hospital (followed in hospitalization and in ambulatory services)

You may qualify if:

• \. Individuals male or female ≥18 years of age at time of enrolment
• Subject (or legally authorized representative provides non opposition form prior to initiation of any study procedure.
• \. Understands and agrees to comply with planned study procedure. (Agrees to the collection of venous blood per protocol).
• \. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen\<72hours prior to enrollment and/or a chest CT scan reported as highly likely SARS-CoV2 infection.
• The different scales for severity are as follows:
• \. Non severe patients: Clinical assessment (evidence of rales/crackles on exam) or CT scan involvement AND SpO2\> 94% on room air, or ≤ 94% on room air but \> 94% with nasal Oxygen with a flow rate \<= 3l O2/min
• For the severe infection's patients' group:
• \. Patients requiring mechanical ventilation and/or supplemental oxygen \>= 6l O2/min
• For the obese patients 'group:
• \. Obese patients will be defined as an BMI \> 30

You may not qualify if:

• Pregnant and breast-feeding women
• Patients previously treated by phenelzine (Nardil®)
• Persons unable to give their no opposition
• Persons under guardianship or curatorship
• No affiliated to social insurance.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHU Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

One blood sample of 60 mL (EDTA)

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Olivier LAMBOTTE, Prof

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: November 20, 2020
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)