Covid-19Phase 1Covid-19NCT04370288
Clinical Application of Methylene Blue for Treatment of Covid-19 Patients
A Phase 1 study testing MCN (Methylene blue, vitamin C, N-acetyl cysteine) in people with Covid-19, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The severe acute respiratory syndrome caused by COVID-19 is now a global catastrophic event. Currently there is no approved drug or vaccine for the disease. Methylene blue (MB, oxidized form, blue color) has been used in many different areas of clinical medicine, ranging from malaria to orthopedics. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Covid-19
- What is being tested?
- MCN (Methylene blue, vitamin C, N-acetyl cysteine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 19 Apr 2020to 21 Sep 2020
- Phase
- Phase 1
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed case of Covid-19 (by RT-PCR, HRCT)
- Admission to Intensive Care Unit
- Need for intubation and mechanical ventilation (PaO2/FiO2 < 100-200)
- Written informed consent
Who cannot join
- Pregnancy and breastfeeding
- History of G6PDH deficiency
- Preadmission anticoagulation
- Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
- Medical records of cirrhosis
- Active chronic hepatitis
Show all 10Show fewer
- Severe hepatic disease defined by GOT or GPT levels three times above the normal upper limit
- Patients with history of allergic reaction or significant sensitivity to Methylene blue
- Treatment with immunosuppressive agents
- Use of other investigational drugs in the moment of inclusion
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Imam Reza Hospital
Mashhad, Razavi Khorasan Province, 9137913316
Ahmad Bagheri Moghaddam, M.D, 05138412081, bagheria@mums.ac.ir
About this study
Official title: The Clinical Trial of Application of Methylene Blue Vial for Treatment of Covid-19 Patients
The severe acute respiratory syndrome caused by COVID-19 is now a global catastrophic event. Currently there is no approved drug or vaccine for the disease. Methylene blue (MB, oxidized form, blue color) has been used in many different areas of clinical medicine, ranging from malaria to orthopedics. Leucomethylene Blue (reduced form of MB, colorless) may be applied for the treatment of COVID-19 according to the scientific evidences.
- Conditions
- Covid-19
- Being tested
- MCN (Methylene blue, vitamin C, N-acetyl cysteine)
- Keywords
- Covid-19, Coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCN (Methylene blue, vitamin C, N-acetyl cysteine)Drug
Also called Leucomethylene Blue
A mixture of MCN will be injected to covid-19 patients.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Covid-19 patients treated with standard medical therapy (supportive therapy). |
| Intervention group | Experimental | Covid-19 patients treated with mixture of MCN (Methylene blue, vitamin C, N-acetyl cysteine). Receives: Drug: MCN (Methylene blue, vitamin C, N-acetyl cysteine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients remaining free of need for mechanical ventilation in both groups
All patient will be assess for changes in disease severity.
Measured: Day 7
Secondary outcomes (7)
Mortality rate in both groups
Measured: Day 28
Improvement in Pa02/Fi02 ratio in both groups
Measured: Day 2
Duration of hospital stay in both group.
Measured: Day 28
Duration of Intensive Care Unit stay in both groups
Measured: Day 28
Days free of dialysis in both groups
Measured: Day 28
C-reactive proteins
Measured: 3-5 Days
WBC Count
Measured: 3-5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start19 Apr 2020
- Primary completion20 Sep 2020 (estimated)
- Study completion21 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daryoush Hamidi Alamdari, Mashhad University of Medical Sciences
- Investigators
- Daryoush Hamidi Alamdari, Ph.D, Principal investigator, Mashhad University of Medical Sciences, Mashhad, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370288
- Sponsor's protocol ID
- IR.MUMS.REC.1399.122
- Acronym
- Covid-19
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hamidi-Alamdari D, Hafizi-Lotfabadi S, Bagheri-Moghaddam A, Safari H, Mozdourian M, Javidarabshahi Z, Peivandi-Yazdi A, Ali-Zeraati A, Sedaghat A, Poursadegh F, Barazandeh-Ahmadabadi F, Agheli-Rad M, Tavousi SM, Vojouhi S, Amini S, Amini M, Majid-Hosseini S, Tavanaee-Sani A, Ghiabi A, Nabavi-Mahalli S, Morovatdar N, Rajabi O, Koliakos G. METHYLENE BLUE FOR TREATMENT OF HOSPITALIZED COVID-19 PATIENTS: A RANDOMIZED, CONTROLLED, OPEN-LABEL CLINICAL TRIAL, PHASE 2. Rev Invest Clin. 2021;73(3):190-198. doi: 10.24875/RIC.21000028.
PubMed 34019535Alamdari DH, Moghaddam AB, Amini S, Keramati MR, Zarmehri AM, Alamdari AH, Damsaz M, Banpour H, Yarahmadi A, Koliakos G. Application of methylene blue -vitamin C -N-acetyl cysteine for treatment of critically ill COVID-19 patients, report of a phase-I clinical trial. Eur J Pharmacol. 2020 Oct 15;885:173494. doi: 10.1016/j.ejphar.2020.173494. Epub 2020 Aug 20.
PubMed 32828741
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Trial of Application of Methylene Blue Vial for Treatment of Covid-19 Patients
- ClinicalTrials.gov ID
- NCT04370288
- Acronym / sponsor ID
- Covid-19 / IR.MUMS.REC.1399.122
- Conditions
- Covid-19
- Keywords
- Covid-19, Coronavirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- 19 Apr 2020 (actual)
- Primary completion
- 20 Sep 2020 (estimated)
- Study completion
- 21 Sep 2020 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The severe acute respiratory syndrome caused by COVID-19 is now a global catastrophic event. Currently there is no approved drug or vaccine for the disease. Methylene blue (MB, oxidized form, blue color) has been used in many different areas of clinical medicine, ranging from malaria to orthopedics. Leucomethylene Blue (reduced form of MB, colorless) may be applied for the treatment of COVID-19 according to the scientific evidences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Covid-19 patients treated with standard medical therapy (supportive therapy). |
| Intervention group | Experimental | Drug: MCN (Methylene blue, vitamin C, N-acetyl cysteine)Covid-19 patients treated with mixture of MCN (Methylene blue, vitamin C, N-acetyl cysteine). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed case of Covid-19 (by RT-PCR, HRCT)
- Admission to Intensive Care Unit
- Need for intubation and mechanical ventilation (PaO2/FiO2 < 100-200)
- Written informed consent
Key exclusion criteria (10 listed)
- Pregnancy and breastfeeding
- History of G6PDH deficiency
- Preadmission anticoagulation
- Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
- Medical records of cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCN (Methylene blue, vitamin C, N-acetyl cysteine)Also: Leucomethylene BlueA mixture of MCN will be injected to covid-19 patients. | Drug | Intervention group |
Primary outcome
Proportion of patients remaining free of need for mechanical ventilation in both groups
Time frame: Day 7
All patient will be assess for changes in disease severity.
7 secondary outcomes
Mortality rate in both groups
Time frame: Day 28
Improvement in Pa02/Fi02 ratio in both groups
Time frame: Day 2
Duration of hospital stay in both group.
Time frame: Day 28
Duration of Intensive Care Unit stay in both groups
Time frame: Day 28
Days free of dialysis in both groups
Time frame: Day 28
C-reactive proteins
Time frame: 3-5 Days
WBC Count
Time frame: 3-5 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Derived from this study: PubMed 34019535Hamidi-Alamdari D, Hafizi-Lotfabadi S, Bagheri-Moghaddam A, Safari H, Mozdourian M, Javidarabshahi Z, Peivandi-Yazdi A, Ali-Zeraati A, Sedaghat A, Poursadegh F, Barazandeh-Ahmadabadi F, Agheli-Rad M, Tavousi SM, Vojouhi S, Amini S, Amini M, Majid-Hosseini S, Tavanaee-Sani A, Ghiabi A, Nabavi-Mahalli S, Morovatdar N, Rajabi O, Koliakos G. METHYLENE BLUE FOR TREATMENT OF HOSPITALIZED COVID-19 PATIENTS: A RANDOMIZED, CONTROLLED, OPEN-LABEL CLINICAL TRIAL, PHASE 2. Rev Invest Clin. 2021;73(3):190-198. doi: 10.24875/RIC.21000028.
- Derived from this study: PubMed 32828741Alamdari DH, Moghaddam AB, Amini S, Keramati MR, Zarmehri AM, Alamdari AH, Damsaz M, Banpour H, Yarahmadi A, Koliakos G. Application of methylene blue -vitamin C -N-acetyl cysteine for treatment of critically ill COVID-19 patients, report of a phase-I clinical trial. Eur J Pharmacol. 2020 Oct 15;885:173494. doi: 10.1016/j.ejphar.2020.173494. Epub 2020 Aug 20.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daryoush Hamidi Alamdari, Ph.D principal investigator
Mashhad University of Medical Sciences, Mashhad, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MCN (Methylene blue, vitamin C, N-acetyl cysteine) in people with Covid-19, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 10 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: status not confirmed, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daryoush Hamidi Alamdari, Ph.D (+98 51 3882 8574, hamidiad@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients remaining free of need for mechanical ventilation in both groups (time frame: Day 7). 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 NCT04370288, which also lists 2 linked publications.
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 4 May 2020.