Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms

NCT05795816 | Completed Phase 3

• 1 other identifier: FENCOV
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Testofen (a specialised extract of Trigonella foenum-graecum (Fenugreek) seed) compared to placebo on post COVID-19 symptoms in otherwise healthy participants 18 years and over.

Conditions

Long Covid19

Outcome Measures

Primary Outcomes (2)

• Change in Energy and Fatigue

  Change in energy and fatigue as measured via Fatigue Severity Scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity

  Baseline, week 4, week 8 and week 12

• Change in Energy and Fatigue

  Change in energy and fatigue as measured via Global Fatigue Index. The items are scored on a 10 point scale with 1 = not at all and 10 = great deal. Higher he score = greater fatigue

  Baseline, week 4, week 8 and week 12

Secondary Outcomes (12)

• Change in Memory

  Baseline, week 4, week 8 and week 12

• Change in Mental Acuity

  Baseline, week 4, week 8 and week 12

• Change in Muscle Strength (Hand grip)

  Baseline, week 4, week 8 and week 12

• Change in Hair loss/growth

  Baseline, week 4, week 8 and week 12

• Change in Libido

  Baseline, week 4, week 8 and week 12

Study Arms (2)

Testofen

ACTIVE COMPARATOR

Testofen in capsule form - taken as 2 x 300 mg daily with food (1 in the morning and 1 in the evening)

Drug: Testofen

Microcrystalline cellulose

PLACEBO COMPARATOR

Microcrystalline cellulose in capsule form - taken as per Active comparator

Drug: Microcrystalline cellulose

Interventions

Testofen DRUG

Twice daily dose of 1 capsule (300mg per capsule Testofen)

Testofen

Microcrystalline cellulose DRUG

Twice daily dose of 1 capsule

Microcrystalline cellulose

Eligibility Criteria

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

You may qualify if:

• Adults 18 years and over
• Able to provide informed consent
• Diagnosed with COVID-19 infection (RAT or PCR test) \>4 weeks, but \< 12 months and experiencing post COVID symptoms (1)
• Agree not to participate in another clinical trial while enrolled in this trial
• Common post COVID symptoms may include fatigue, cough, chest pain, hair loss, weakness, joint pain, cardiac issues, neurocognitive impairment including memory loss, and decreased quality of life

You may not qualify if:

• Symptoms resulting from vaccination (2)
• Unstable or serious illness (e.g., serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland dysfunction) (3)
• Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
• Receiving/prescribed coumandin (Warfarin), heparin, dalteaparin, enoxaparin or other anticoagulation therapy
• Receiving pharmaceutical treatment for anxiety, libido, low energy
• Active smokers, nicotine use, alcohol, or drug (prescription or illegal substances) abuse
• Chronic past and/or current alcohol use (\>14 alcoholic drinks per week)
• Allergic to any of the ingredients in the active or placebo formula
• Known pregnant or lactating women
• Participants who have participated in any other related clinical study during the past 1 month
• History of infection in the month prior to the study
• (2) Symptoms must be as a direct result of having contracted COVID. If symptoms only appeared within 2 weeks of a vaccination it will be considered a vaccine injury and not classed as a result of COVID.
• (3) An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amanda Rao, PhD

  RDC Clinical Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 3, 2023
• Study Start: October 25, 2023
• Primary Completion: January 30, 2025
• Study Completion: January 31, 2025
• Last Updated: March 10, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)