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COVID-19 Respiratory InfectionCOVID-19NCT05234346

ALACOVID Study for Vaccinated Subjects

A study testing 150 mg 5-ALAPhosphate + SFC in people with COVID-19 Respiratory Infection, run by Vedic Lifesciences Pvt. Ltd. at 4 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, it is hypothesized that administration of 5-ALA-Phosphate + SFC in subjects vaccinated against Covid-19 could contribute in enhancing the targeted function of the immune system, which might lead to re-activation and/or increase of the vaccination response. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
COVID-19 Respiratory Infection
What is being tested?
150 mg 5-ALAPhosphate + SFC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
4 sitesIndia
Study dates
15 Mar 2022to 18 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male \& female aged ≥ 18 years and ≤70 years.
  • Subjects with documented proof of 1st dose of vaccination within 3 months of planned 2nd dose. (If government of India implements booster dose then subjects needs to have a documented proof of 2nd dose)
  • Subjects planning to have 2nd /3rd dose of COVID-19 vaccine (Covishield/ Covaxin). (If government of India implements booster dose then subjects planning to have a 3rd dose of vaccine will be included in this study)
  • Subject willing and able to provide a written informed consent

Who cannot join

  • Subjects with anemia (male: <12 g/dl, females: <11 g/dl)
  • Subjects with more than 2.5 times upper limit of ALT \& AST parameters.
  • Subjects not willing to stop intake of any vitamin/s or mineral/s supplements during the trial except for those allowed in the study.
  • Subjects with acute symptomatic COVID-19 infection indicated by fever, dry cough and severe respiratory distress.
  • Subjects with SpO2 < 90%.
  • Subjects with history of genetic disorders.
Show all 32Show fewer
  • Subjects with history of:
  • Anaphylactic or allergic reaction to a previous dose of COVID-19 vaccine
  • Immediate or delayed-onset anaphylaxis or allergic reaction to vaccines or injectable therapies, pharmaceutical products, food-items etc.
  • Pregnancy \& Lactation:
  • Pregnant \& Lactating women have not been part of any COVID-19 vaccine clinical trial so far. Therefore, women who are pregnant or not sure of their pregnancy; and lactating women should not receive COVID-19 vaccine at this time
  • Provisional / temporary contraindications:
  • Persons having active symptoms of SARS-CoV-2 infection.
  • SARS-COV-2 patients who have been given anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma
  • Signs of acute infection or illness
  • Hospitalized patients due to any illness.
  • Subjects with known history (diagnosed case) of porphyria, or chronic serious liver disease, kidney disease or heart problems.
  • Subjects with frequent complaints of cold, fever, cough.
  • Subjects with irritable bowel syndrome.
  • Subjects who are frequent travelers or are planning to travel.
  • Subject has demonstrated previous intolerance of 5-ALA and/or SFC by topical or oral administration.
  • Subjects with known allergy to 5-ALA containing foods (spinach, shitake mushroom, octopus, baker's yeast, wine, vinegar, sake less).
  • Subjects on vitamin D supplements
  • Males and females of reproductive potential who have not agreed to use an adequate method of contraception during the study
  • For females, adequate birth control methods will be defined as: hormonal contraceptives, intrauterine device or double barrier contraception, i.e., condom
  • + diaphragm, condom or diaphragm + spermicidal gel or foam.
  • For males, adequate birth control methods will be defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.
  • For females, menopause is defined as one year without menses; if in question, a follicle-stimulating hormone of >40 U/ml must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable.
  • Subjects who are unable or unwilling to comply with requirements of the clinical trial.
  • Participation in any other clinical trial of an experimental treatment for COVID-19.
  • Subjects having any other family member participating in this study.
  • Subjects who may be excluded at the Investigator's discretion.

Trial locations and contacts

4 sites in 1 country.

India4 sites

  • BAJ RR Hospital and Research Centre

    Dombivali, Maharashtra, 421203

  • JNU Institute for Medical Sciences and Research Centre

    Jaipur, Rajasthan, 302017

  • Leelawati Care Hospital-Nasik (SMO)

    Nashik, Maharashtra, 422005

  • Ranka Hospital

    Pune, Maharashtra, 411037

Other trials in India

About this study

Official title: An Open-Label, Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of 5-ALA-Phosphate + SFC as an Immune System Enhancer Along With Vaccination Against SARS-CoV-2 Virus Infection

In this study, it is hypothesized that administration of 5-ALA-Phosphate + SFC in subjects vaccinated against Covid-19 could contribute in enhancing the targeted function of the immune system, which might lead to re-activation and/or increase of the vaccination response. Thus, in the present study, we will be evaluating the safety and efficacy of 5-ALA-Phosphate + SFC in subjects receiving the Covid-19 vaccine.

Being tested
150 mg 5-ALAPhosphate + SFC, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 150 mg 5-ALAPhosphate + SFCDrug

    2 capsules in the morning after breakfast (before 11 AM) and 1 capsule in the evening after a snack or after dinner (before 8 PM) orally with water for 21 days.

  • PlaceboOther

    No Description for the intervention

Study groups in NCT05234346
Study groupRoleWhat they receive
150 mg 5-ALAPhosphate + SFCExperimental2 capsules in the morning after breakfast (before 11 AM) and 1 capsule in the evening after a snack or after dinner (before 8 PM) orally with water for 21 days.
Receives: Drug: 150 mg 5-ALAPhosphate + SFC
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse product reaction

    To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.

    Measured: Day 0

  2. Adverse product reaction

    To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.

    Measured: Day 1

  3. Adverse product reaction

    To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.

    Measured: Day 7

  4. Adverse product reaction

    To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.

    Measured: Day 21

Secondary outcomes (4)

  1. Absolute change in GMT of IgG levels against Covid-19 spike protein

    Elecsys Anti-SARS-CoV-2 S kit will be used to measure the levels of IgG post vaccination on baseline and at the end of the study (day 21).

    Measured: Day 0 and Day 21

  2. European Quality of Life Five Dimension Five level questionnaire

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The subject is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the subject's health state. The Lower level is denoted as 1 and the highest level is denoted as 5. The EQ-5D-5L QoL questionnaire will be completed by the subject.

    Measured: Day 0 , Day 1, Day 7 and Day 21

  3. World Health Organization Well-Being Index questionnaire

    The 5-item World Health Organization Well-Being Index (WHO-5) is a short and generic global rating scale measuring subjective well-being.

    Measured: Day 0 , Day 1, Day 7 and Day 21

  4. Visual Analogue Scale for pain and fatigue

    The subjects is asked to place a line perpendicular to the VAS line at the point that represents their current situation for pain and fatigue (question 4). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity

    Measured: Day 0 , Day 1, Day 7 and Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2022
  2. Study start15 Mar 2022
  3. Primary completion18 Jun 2022
  4. Study completion18 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Model description
An Open-Label, Pilot Study
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05234346
Sponsor's protocol ID
PH/210904/5ALP/COVID
Acronym
COVID-19
Status last verified
May 2022
First submitted
5 Feb 2022
Last updated
11 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 150 mg 5-ALAPhosphate + SFC in people with COVID-19 Respiratory Infection, run by Vedic Lifesciences Pvt. Ltd. at 4 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse product reaction (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05234346.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022; AzTrials last refreshed its copy on 2 Nov 2026.

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