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LACTYFERRIN™ Forte and ZINC Defense™ and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19

NCT05783180 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-11-13

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about the safety and efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ in non-hospitalized patients with COVID-19.

The main question is:

Is there a reduction in the signs and symptoms of COVID-19 from baseline to end of treatment? Participants will complete the following activities.

* Screening and first day of treatment
* Treatment that will be administered for up to 10 days, two treatment evaluation visits will be completed
* After treatment completion. Two visits are scheduled, one 28 days after the last dose and the other 60 days after the last dose.

Researchers will compare Treatment Group (Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ + Standard of care (SOC)) with the Control group (Placebo +SOC) to see if there is Reduction in the signs and symptoms of COVID-19 at the end of treatment

Conditions

Interventions

DRUG

Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™

Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD)

DRUG

Placebo

Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Placebo)

Sponsors & Collaborators

  • Sesderma S.L.

    collaborator UNKNOWN

  • Westchester General Hospital Inc. DBA Keralty Hospital Miami

    collaborator UNKNOWN

  • MGM Technology Corp

    collaborator UNKNOWN

  • Jose David Suarez, MD

    lead OTHER

Principal Investigators

  • Jose D Suarez · Keralty Hospital, Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2023-06-30
Completion
2024-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05783180 on ClinicalTrials.gov