Extension Study in a Cohort of Adult Patients With COVID-19 Infection (E-APLICOV-PC)

Pharma Mar

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19 Infection

Treatments: Drug: Plitidepsin 1.5 mg / day; Drug: Plitidepsin 2.0 mg / day; Drug: Plitidepsin 2.5 mg / day

Study type: Interventional

Funder types: Industry

Identifiers

NCT05121740

AV-APL-A-003-21

2021-004966-37 (EudraCT Number)

Details and patient eligibility

About

The main objective of this study is to evaluate the incidence of post-COVID morbidity and characterize the complications profile in patients who participated in the APLICOV-PC study. APLICOV-PC study was a multicenter, randomized, proof-of-concept clinical trial to assess the safety profile of 3 different dose levels of plitidepsin (1,5 mg, 2,0 mg and 2,5 mg) administered three consecutive days, in adult patients with confirmed diagnosis of COVID-19 who require hospital admission.

Full description

The APLICOV-PC proof of concept study demonstrated the antiviral activity of plitidepsin in terms of reducing viral load, inducing recovery, and impact on lymphocyte reconstitution and other inflammatory parameters.

A percentage of patients, which varies between 10 and 25%, continue to show symptoms at 3 months after contracting the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: For some of them this significantly restricts their life, requiring them to take long-term sickness leave from work, and leaving them with sequelae that may continue for more than one year.

With this study, Pharmamar intends to evaluate whether the treatment with plitidepsin, by attaining a reduction in the viral load and a faster recovery of the patient, could have a relevant impact on the emergence of sequelae resulting from the SARS-CoV-2 infection.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient who participated in the APLICOV-PC study receiving treatment with plitidepsin and who gives consent.

Exclusion criteria

• There are no exclusion criteria for this study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 3 patient groups

Arm A: Experimental 1

Experimental group

Description:

In the APLICOV-PC study, patients of arm A received 1.5 mg of plitidepsin / day for 3 consecutive days (total dose 4.5 mg).

Treatment:

Drug: Plitidepsin 1.5 mg / day

Arm B: Experimental 2

Experimental group

Description:

In the APLICOV-PC study, patients of arm B received 2.0 mg of plitidepsin / day for 3 consecutive days (total dose 6.0 mg).

Treatment:

Drug: Plitidepsin 2.0 mg / day

Arm C: Experimental 3

Experimental group

Description:

In the APLICOV-PC study, patients of arm C received 2.5 mg of plitidepsin / day for 3 consecutive days (total dose 7.5 mg).

Treatment:

Drug: Plitidepsin 2.5 mg / day