Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection

Inmunotek

Status and phase: Unknown; Phase 3

Conditions: COVID-19

Treatments: Biological: Bactek-R

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04363814

MV130-SLG-35

Details and patient eligibility

About

The purpose of the study is to confirm if BACTEK-R (MV130) provides clinical benefit in subject with mild pneumonia (CURB-65≤2) by COVID-19 admitted to the Hospital.

Full description

This is a prospective, open-label, randomized pilot study to evaluate the efficacy and safety of BACTEK-R (MV130) in subject with mild pneumonia due to COVID-19 infection.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. • Subjects who voluntarily sign informed consent forms
2. • Both genders.
3. • Subjects aged between 18 and 70 years.
4. -Subjects capable of complying with the treatment
5. • Subjects admitted to hospital with non-severe pneumonia (CURB-65≤2) by COVID-19
6. • Confirmatory test for COVID-19 infection

Exclusion criteria

1. • Subjects who has not signed informed consent forms
2. • Subjects included in another clinical trial.
3. • Subjects under treatment with immunosuppressants.
4. • Subjects in treatment with another type of immunotherapy.
5. • Subjects who are or have been undergoing treatment with metformin.
6. • Subjects who are or have been treated with statins.
7. • Subjects who are or have been under treatment with sertraline.
8. • Pregnant women.
9. • Subjects who cannot offer cooperation and / or have serious psychiatric disorders.
10. -Subjects who are allergic to any of the components of BACTEK-R (MV130).
11. • Subjects with pathologies described in the Charlson index

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Bactek-R

Experimental group

Description:

Subject included in the experimental group will receive Bactek- R.The dose consists on 3 spray puff every 6 hours for 2 weeks.

Treatment:

Biological: Bactek-R

Control

No Intervention group

Description:

Subject included in the control group will receive standard therapy for COVID-19.