COVID-19 PandemicPhase 1/2NCT05451654
NanoMn®_COVID-19 A Prospective, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blind Trial to Evaluate the Clinical Efficacy of NanoManganese® on Top of Standard of Care, in Adult Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19)
A Phase 1/2 study testing Experimental drug in people with COVID-19 Pandemic, run by Medesis Pharma SA at 1 site in Brazil.
Trial summary
This is a prospective, multicenter, randomized (3:1), placebo- controlled, parallel-group, double-blind trial. Patients will be randomized into two arms of treatment: Placebo + SoC (N=30) NanoManganese® + SoC (N=90) Patients will be treated and followed-up for 10 days: Arterial oxygen partial pressure (PaO2) will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Experimental drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Feb 2022to 1 Dec 2022
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patient aged ≥ 18 years
- Patient hospitalized with positive COVID-19, confirmed by a Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or an antigen test done ≤ 7 days before study entry
- Patient with at least 1 of the National Institutes of Health COVID- 19 clinical symptoms (Fever or chills, Cough, Shortness of breath or difficulty breathing, Fatigue, Muscle or body aches, Headache, New loss of taste or smell, Sore throat, Congestion or runny nose, Nausea or vomiting, Diarrhea) that appeared ≤ 15 days before study entry
- Patient with a peripheral capillary oxygen saturation (SpO2) < 96%, or with an arterial oxygen partial pressure (PaO2) ≤65 mmHg, at study entry
- Female patient of childbearing potential must be willing to use an efficient birth control method during the study and until 3 months after IMP administration.
- A woman is considered to be of childbearing potential if she is post menarche, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus, tubal ligation). The following are acceptable contraceptive methods: - Established use of oral, injected, or implanted hormonal methods of contraception - Intrauterine system or placement of an intrauterine device - Double barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, cream, or suppository - True abstinence [periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception]
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- Male patient must be willing to use male contraception (condom) during the study, avoid donating semen during study and until 3 months after last dose of IMP administration.
- Patient must sign the informed consent form
- Patient who have or have not been vaccinated for COVID-19 (1, 2, 3 or 4 shots) can enter the study
Who cannot join
- Refusal to participate expressed by patient
- Pregnancy or breast-feeding
- Anticipated transfer to another hospital, which is not a study site within 72 hours
- Contraindication to Manganese supplementation
- Patient under Long-term oxygen therapy or invasive ventilation prior to COVID-19 infection
- Patient requiring Continuous Positive Airway Pressure (CPAP), high flow, or Non-Invasive Ventilation (NIV) and a SpO2 <92%
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- Patient on invasive mechanical ventilation
- Patient with homozygotic sickle cell disease or methemoglobin.
- Patient receiving a biotherapy as a SoC for COVID-19
- Patient participating in another drug trial
- Patient under guardianship or prisoner
- Patient with a written order for restricted care
- Patient allergic to peanut or soja
- Patient under parenteral nutrition (with Mn in composition)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blind Trial to Evaluate the Clinical Efficacy of NanoManganese® on Top of Standard of Care, in Adult Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19)
This is a prospective, multicenter, randomized (3:1), placebo- controlled, parallel-group, double-blind trial.
Patients will be randomized into two arms of treatment:
Read more
- Placebo + SoC (N=30)
- NanoManganese® + SoC (N=90)
Patients will be treated and followed-up for 10 days:
- Arterial oxygen partial pressure (PaO2) will be measured at baseline and at days 3, 5 and 10,
- Oxygen saturation, vital signs including respiration rate, pulse rate, blood pressure and body temperature, disease severity (7-point ordinal scale and NEWS2 score) will be measured at baseline and daily,
- Hematology and biochemistry measurements will be done at baseline and at day 3, 5 and 10,
- Pharmacokinetic (Blood Mn concentration) measurements will be done at baseline and at day 3, 5 and 10,
- Biomarkers will be measured at baseline and at day 3, 5 and 10. At the end of the 10-day treatment period, a follow-up visit will be planned between day 15 and day 22. The following. assessments/examinations will be performed: oxygen saturation, vital signs including respiration rate and body temperature, disease severity (7-point ordinal scale and NEWS2 score), electrocardiogram (ECG), hematology, biochemistry, concomitant therapies, and adverse events.
Read the detailed description
120 patients will be enrolled in this study, they will be randomly assigned in 2 arms on a 3:1 ratio, 90 patients in the NanoManganese®
+ Standard of Care group and 30 patients in the placebo + Standard of Care group.
This study will be conducted in Brazil and will be conducted in around 8 investigational sites
The investigational products are :
Manganese sulfate monohydrate, MnSO4, H2O (NanoManganese®) will be administered using the microemulsion AONYS® technology. The product is mucoadhesive, it sticks to the mucosa of the cheeks on which it will be deposited and will not be swallowed.
The placebo (Pharmacopoeia soybean oil) will be administered using the same protocol and the same bottle.
Treatments :
NanoManganese® + standard of care group:
- NanoManganese®: administration of 2 mL twice a day (morning and evening) by depositing 1 mL in the gingivo-jugal groove of each cheek with the graduated pipette.
- Standard of care
Placebo + standard of care group:
- Placebo: administration of 2 mL twice a day (morning and evening) by depositing 1 mL in the gingivo-jugal groove of each cheek with the graduated pipette.
- Standard of care The treatments will be administered by the nurse. Duration of treatment: 10 days or until hospital discharge or until death.
- Conditions
- COVID-19 Pandemic
- Being tested
- Placebo, Experimental drug
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
The administration of the treatment consists in a deposit in the gingivo-jugal groove of each cheek with a graduated pipette
Experimental drugDrug
The administration of the treatment consists in a deposit in the gingivo-jugal groove of each cheek with a graduated pipette
| Study group | Role | What they receive |
|---|---|---|
| Placebo + SoC (N=30) | Placebo comparator | This arm is composed by 30 patients.
* Placebo: administration of 2 mL twice a day (morning and evening) by depositing 1 mL in the gingivo-jugal groove of each cheek with the graduated pipette.
* Standard of care Receives: Drug: Placebo |
| NanoManganese® + SoC (N=90) | Experimental | This arm is composed by 90 patients.
NanoManganese® + standard of care group:
* NanoManganese®: administration of 2 mL twice a day (morning and evening) by depositing 1 mL in the gingivo-jugal groove of each cheek with the graduated pipette.
* Standard of care Receives: Drug: Experimental drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the PaO2/FiO2 ratio
Change from baseline to D10 of the PaO2/FiO2 ratio in the NanoManganese® + SoC group and in the placebo+ SoC group.
Measured: 10 days
Secondary outcomes (19)
Proportion of patients with PaO2 > 65 mmHg
Proportion of patients with PaO2 > 65 mmHg at D3, at D5 and at D10, measured preferable after IP administration in the morning.
Measured: 10 days
Change of PaO2
Change between baseline and D10 of PaO2
Measured: 10 days
Evolution of respiratory rate over time
Evolution of respiratory rate over time
Measured: 10 days
Proportion of patients with SpO2 ≥ 95%
Proportion of patients with SpO2 ≥ 95% at D3, D5 and at D10,
Measured: 10 days
Change of SpO2
Change between baseline and D10 of SpO2,
Measured: 10 days
Incidence of oxygen use
Measured: 10 days
Duration of oxygen use
Measured: 10 days
Oxygen free days at D15-22 after inclusion
Measured: 10 days
Incidence of noninvasive support (high flow, CPAP, NIV) use
Measured: 10 days
Duration of noninvasive support (high flow, CPAP, NIV) use
Measured: 10 days
Noninvasive support (high flow, CPAP, NIV) free days during follow- up (between D15 and D22 after inclusion
Measured: 10 days
Incidence of invasive mechanical ventilation use,
Measured: 10 days
Duration of invasive mechanical ventilation use
Measured: 10 days
Invasive mechanical ventilation free days during follow-up (between D15 and D22 after inclusion)
Measured: 10 days
Time to improvement of 1 level on seven point ordinal scale
Higher scores indicate a worse outcome
- - Not hospitalized, no limitation of activities
- - Not hospitalized, limitation of activities
- - Hospitalized, not requiring supplemental oxygen
- - Hospitalized, requiring supplemental oxygen
- - Hospitalized, on non-invasive ventilation or high flow oxygen devices
- - Hospitalized, on invasive mechanical ventilation or ECMO
- - Death
Measured: 10 days
Clinical status assessed by ordinal scale
Measured: 10 days
Proportion of patient transferred in ICU
Measured: 10 days
Description of ICU-free days during follow-up (between D15 and D22 after inclusion)
Measured: 10 days
Overall survival at day 22 and cause of death
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start4 Feb 2022
- Primary completion4 Oct 2022
- Study completion1 Dec 2022
Why it stopped: the number of patients recruited was not reached because covid cases were low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medesis Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451654
- Sponsor's protocol ID
- 2020NanoMn-CT01
- Status last verified
- Oct 2023
- First submitted
- 7 Jul 2022
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blind Trial to Evaluate the Clinical Efficacy of NanoManganese® on Top of Standard of Care, in Adult Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT05451654
- Acronym / sponsor ID
- 2020NanoMn-CT01
- Conditions
- COVID-19 Pandemic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the number of patients recruited was not reached because covid cases were low
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Medesis Pharma SAIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 11 Jul 2022 (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.
This is a prospective, multicenter, randomized (3:1), placebo- controlled, parallel-group, double-blind trial.
Patients will be randomized into two arms of treatment:
- Placebo + SoC (N=30)
- NanoManganese® + SoC (N=90)
Patients will be treated and followed-up for 10 days:
- Arterial oxygen partial pressure (PaO2) will be measured at baseline and at days 3, 5 and 10,
- Oxygen saturation, vital signs including respiration rate, pulse rate, blood pressure and body temperature, disease severity (7-point ordinal scale and NEWS2 score) will be measured at baseline and daily,
- Hematology and biochemistry measurements will be done at baseline and at day 3, 5 and 10,
- Pharmacokinetic (Blood Mn concentration) measurements will be done at baseline and at day 3, 5 and 10,
- Biomarkers will be measured at baseline and at day 3, 5 and 10. At the end of the 10-day treatment period, a follow-up visit will be planned between day 15 and day 22. The following. assessments/examinations will be performed: oxygen saturation, vital signs including respiration rate and body temperature, disease severity (7-point ordinal scale and NEWS2 score), electrocardiogram (ECG), hematology, biochemistry, concomitant therapies, and adverse events.
Detailed description
120 patients will be enrolled in this study, they will be randomly assigned in 2 arms on a 3:1 ratio, 90 patients in the NanoManganese®
+ Standard of Care group and 30 patients in the placebo + Standard of Care group.
This study will be conducted in Brazil and will be conducted in around 8 investigational sites
The investigational products are :
Manganese sulfate monohydrate, MnSO4, H2O (NanoManganese®) will be administered using the microemulsion AONYS® technology. The product is mucoadhesive, it sticks to the mucosa of the cheeks on which it will be deposited and will not be swallowed.
The placebo (Pharmacopoeia soybean oil) will be administered using the same protocol and the same bottle.
Treatments :
NanoManganese® + standard of care group:
- NanoManganese®: administration of 2 mL twice a day (morning and evening) by depositing 1 mL in the gingivo-jugal groove of each cheek with the graduated pipette.
- Standard of care
Placebo + standard of care group:
- Placebo: administration of 2 mL twice a day (morning and evening) by depositing 1 mL in the gingivo-jugal groove of each cheek with the graduated pipette.
- Standard of care The treatments will be administered by the nurse. Duration of treatment: 10 days or until hospital discharge or until death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + SoC (N=30) | Placebo comparator | Drug: PlaceboThis arm is composed by 30 patients. * Placebo: administration of 2 mL twice a day (morning and evening) by depositing 1 mL in the gingivo-jugal groove of each cheek with the graduated pipette. * Standard of care |
| NanoManganese® + SoC (N=90) | Experimental | Drug: Experimental drugThis arm is composed by 90 patients. NanoManganese® + standard of care group: * NanoManganese®: administration of 2 mL twice a day (morning and evening) by depositing 1 mL in the gingivo-jugal groove of each cheek with the graduated pipette. * Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female patient aged ≥ 18 years
- Patient hospitalized with positive COVID-19, confirmed by a Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or an antigen test done ≤ 7 days before study entry
- Patient with at least 1 of the National Institutes of Health COVID- 19 clinical symptoms (Fever or chills, Cough, Shortness of breath or difficulty breathing, Fatigue, Muscle or body aches, Headache, New loss of taste or smell, Sore throat, Congestion or runny nose, Nausea or vomiting, Diarrhea) that appeared ≤ 15 days before study entry
- Patient with a peripheral capillary oxygen saturation (SpO2) < 96%, or with an arterial oxygen partial pressure (PaO2) ≤65 mmHg, at study entry
- Female patient of childbearing potential must be willing to use an efficient birth control method during the study and until 3 months after IMP administration.
Key exclusion criteria (14 listed)
- Refusal to participate expressed by patient
- Pregnancy or breast-feeding
- Anticipated transfer to another hospital, which is not a study site within 72 hours
- Contraindication to Manganese supplementation
- Patient under Long-term oxygen therapy or invasive ventilation prior to COVID-19 infection
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 |
|---|---|---|
| PlaceboThe administration of the treatment consists in a deposit in the gingivo-jugal groove of each cheek with a graduated pipette | Drug | Placebo + SoC (N=30) |
| Experimental drugThe administration of the treatment consists in a deposit in the gingivo-jugal groove of each cheek with a graduated pipette | Drug | NanoManganese® + SoC (N=90) |
Primary outcome
Change of the PaO2/FiO2 ratio
Time frame: 10 days
Change from baseline to D10 of the PaO2/FiO2 ratio in the NanoManganese® + SoC group and in the placebo+ SoC group.
19 secondary outcomes
Proportion of patients with PaO2 > 65 mmHg
Time frame: 10 days
Change of PaO2
Time frame: 10 days
Evolution of respiratory rate over time
Time frame: 10 days
Proportion of patients with SpO2 ≥ 95%
Time frame: 10 days
Change of SpO2
Time frame: 10 days
Incidence of oxygen use
Time frame: 10 days
Duration of oxygen use
Time frame: 10 days
Oxygen free days at D15-22 after inclusion
Time frame: 10 days
Incidence of noninvasive support (high flow, CPAP, NIV) use
Time frame: 10 days
Duration of noninvasive support (high flow, CPAP, NIV) use
Time frame: 10 days
Noninvasive support (high flow, CPAP, NIV) free days during follow- up (between D15 and D22 after inclusion
Time frame: 10 days
Incidence of invasive mechanical ventilation use,
Time frame: 10 days
Duration of invasive mechanical ventilation use
Time frame: 10 days
Invasive mechanical ventilation free days during follow-up (between D15 and D22 after inclusion)
Time frame: 10 days
Time to improvement of 1 level on seven point ordinal scale
Time frame: 10 days
Clinical status assessed by ordinal scale
Time frame: 10 days
Proportion of patient transferred in ICU
Time frame: 10 days
Description of ICU-free days during follow-up (between D15 and D22 after inclusion)
Time frame: 10 days
Overall survival at day 22 and cause of death
Time frame: 10 days
Results and safety
The study was stopped early (reason given: the number of patients recruited was not reached because covid cases were low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Experimental drug in people with COVID-19 Pandemic, run by Medesis Pharma SA at 1 site in Brazil.
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 9 inclusion and 14 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: stopped early, as of the sponsor's last update on 26 Oct 2023. 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 Brazil. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the number of patients recruited was not reached because covid cases were low). Results are not available in the source record.
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?
Change of the PaO2/FiO2 ratio (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2023.