Covid19LACNCT04847791
Lactoferrin in Covid-19 Hospitalized Patients
A study testing Bovine lactoferrin in people with Covid19, run by Paolo Manzoni at 2 sites in Italy.
Trial summary
TRIAL LAC is a randomized double-blind non profit multicenter study with a nutritional product: bovine lactoferrin - Mosiac 200 mg. the hypothesis to be confirmed is that bovine LF, administered daily orally in addition to standard therapies for 1 month to hospitalized patients with Covid-19 infection, can be useful… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Covid19
- What is being tested?
- Bovine lactoferrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 2 sitesItaly
- Study dates
- 14 Jan 2021to 31 Dec 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalization in non-ICU ward for Covid-19 infection, with virological diagnosis SARS-CoV2 confirmed via RT-PCR (or quick test)
- Age>18 aa
- Covid symptomatology story from no more than 12 days
Who cannot join
- Refusal of consent
- Need for immediate admission to intensive care
- Severe neoplasms (in advanced stage)
- Allergies or intolerances known to Lactoferrin
- 4. Already being treated with Lactoferrin at the entrance to the Hospital 5. Patients with end-stage renal failure (stage 5) 6. Extremely serious general conditions to suggest an imminent exitus 7. Clinical conditions of absolute impossibility of tolerating ingestion of drugs/capsules due to conditions contraining the initiation of therapy for os.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
AOU Ospedale Maggiore della Carità
Novara, 28100
Pier Paolo Sainaghi, MD
- Recruiting
ASL BI Ospedale degli Infermi
Ponderano, Biella, 13875
Paolo Manzoni, MD, 0151515 ext. 7626, paolomanzoni@hotmail.com
About this study
Official title: Lactoferrin for Treatment of Acute COVID-19 Infection in Hospitalized Patients: a Double-blind Multicenter Placebo-controlled Randomized Trial
TRIAL LAC is a randomized double-blind non profit multicenter study with a nutritional product: bovine lactoferrin - Mosiac 200 mg.
the hypothesis to be confirmed is that bovine LF, administered daily orally in addition to standard therapies for 1 month to hospitalized patients with Covid-19 infection, can be useful to limit the severity, progression of the disease, shorten the time of swabs negativization (i.e. time required to eliminate the virus) and to reduce the morbidity load associated with it.
Read more
Patient recruitment will involve 2 centers in Italy: Ospedale degli Infermi (Ponderano, Biella) and AOU Maggiore della Carità (Novara).
The subjects enrolled will be randomized to two Groups:
Group A (experimental arm) - Standard Anti-Covid-19 Therapy + Oral Administration of Bovine Lactoferrin (fixed dose 800 mg / day) for 30 days Group B (control arm) - Standard anti-Covid-19 therapy + Placebo administration (identical capsule with the same amount as an inert compound, starch of corn powder), according to the same pattern of use.
It should be specified that the study treatment and placebo will be administered in addition to the standard care in place, and therefore in addition to all the pharmacological treatments currently used in clinical hospital practice against Covid-19.
Read the detailed description
It has been shown with 'in vitro' studies that LF is able to prevent the entry of SARS-CoV-2 into the of the host cells.
Overall, the available evidence suggests that LF may be a therapeutic option that can be used to counteract and reduce the severity of Covid 19 infection. The study hase been designed in order to demonstrate efficacy of Lactoferrin in vivo.
Patients who will be admitted by Participating Centers for Covid-19 Infection will be screened for eligibility for study . If considered eligible, they will be offered participation in the Study, and it will be proposed and informed consent will be explained. Eligible patients will be registered in a centralized database at the IT systems of the University of Piedmont Orientale (UPO)/Hospital-University Company "Maggiore della Carità" of Novara. The pseudo-anonymized patient data will be recorded by the clinical centre in an 'ad hoc' Clinical Report Form with web-based access.
After obtaining informed consent, patients will then be randomised to LF or placebo group allocation using previous randomization lists Prepared. Randomization will take place on a competitive and balanced basis per clinical center participant. Permuted block randomization of size 4 will be implemented with an allocation ratio of 1:1 to ensure the balance between the groups of treatment. The randomization list will be managed through a REDCap randomization module.
The Hospital Pharmacy of the Participating Center, not involved in the enlistment of patients, will prepare a numbered sequence of sealed envelopes containing the code of allocation, and will keep its list that will remain inaccessible to the professionals involved in recruitment.These sealed envelopes will be opened sequentially, at the time of randomization.
The maintenance of the blind person will be guaranteed by keeping the staff randomization lists, i.e. the staff of the Hospital Pharmacy, on the one hand (staff who will also manage and deliver to the investigators the products being studied, which will look the same), and the randomizing and experimenting medical staff, on the other.
The logistical location of the two staff will also be completely separated, in sectors of the Hospital different and distant from each other, and not communicating in any way.
It should be pointed out that the patient enrolled by the clinical centers on the basis of the selection criteria can start standard-of-care therapy, in any case, before the randomization procedure being the identical basic therapeutic regimen in the two study arms.
For the calculation of the sample size required to demonstrate the primary endpoint, it was used a model built on historical data regarding the same endpoint. Pre-trial data from the two Participating Centres estimate the need for ICU admission at 25%; the need for mechanical ventilation in 30%; hospital mortality in 15%; the average duration hospitalization in 16 days.
The sample size was determined considering a two-sided t-test for two independent samples according to the following parameters:
- A correct alpha level of 0.025 for two Bonferroni-method endpoints (Alpha total=0.025x2=0.05)
- A total power of 0.8
- A Cohen h effect size of 0.44 (corresponding to an effect standardized medium/small [Cohen 1977]), i.e. with a 14-day resignation rate of 60% for controls and 80% for treaties.
In this scenario, the size of the study achieved consists of 97 patients per arm of study. Calculations were performed using the R 3.6.1 software [Core Team 2015] and the pwr package [Champely 2018]. references:
- Cohen, J. Statistical power analysis for the behavioral sciences (rev.ed.1977).
- Core Team R: A Language and Environment for Statistical Computing; R Foundation for Statistical Computing: Vienna, Austria, 2015;
- Champely, S.; Ekstrom, C.; Dalgaard, P.; Gill, J.; Weibelzahl, S.; Anandkumar, A.;Ford, C.; Volcic, R.; De Rosario, H.; De Rosario, M.H. Package 'pwr.' R package version 2018, 1-2.
- Conditions
- Covid19
- Being tested
- Bovine lactoferrin, Placebo administration
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine lactoferrinDietary supplement
Also called MOSIAC
Oral Administration of Bovine Lactoferrin -fixed dose 800 mg / day for 30 days
Placebo administrationDietary supplement
capsule identical with the same amount as an inert compound, starch of corn powder), according to the same pattern of use.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Standard Anti-Covid-19 Therapy + Oral Administration of Bovine Lactoferrin 400mg (two capsules of Mosiac 200 product) every 12 h (i.e., fixed dose 800 mg / day) for 30 days and still away from meals Receives: Dietary Supplement: Bovine lactoferrin |
| Group B | Placebo comparator | Standard anti-Covid-19 therapy + Placebo administration (capsule identical with the same amount as an inert compound, starch of corn powder), according to the same pattern of use. Receives: Dietary Supplement: Placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensive care unit hospitalization rate
The primary endpoint will be to evaluate the efficacy of bovine LF orally (BLF- Mosiac) compared to placebo in affecting at least one of the following:
- it is expected a reduction of a composite event rate consisting of two items: the number of hospitalizations in intensive care unit due to any cause and the number of deaths
Measured: 1 year
death
number of deaths during hospitalization
Measured: 1 year
proportion of discharged patients
The primary endpoint will be to evaluate the efficacy of bovine LF orally (BLF- Mosiac) compared to placebo in affecting at least one of the following:
- it is expected an increase of proportion of discharged patients within 14 days and an increase of number of patients reaching a National Early Warning Score (NEWS) of 2 or less
Measured: 1 year
National Early Warning Score (NEWS)
it is expected an increase of number of patients reaching a National Early Warning Score (NEWS) of 2 or less, maintained for at least 24hrs
Measured: during hospitalization
Secondary outcomes (9)
daily clinical severity score
Secondary Endpoints will be the assessment of a possible superiority of the experimental treatment compared to the standard treatment with regard to improving of the daily clinical severity score detected from the day of hospitalization to that of discharge and considering all the oucome hereafter listed
Measured: during hospitalization
oxygen
the assessment of a possible superiority of the experimental treatment will be evaluated considering the need for additional oxygen (yes/no), and number of days of use
Measured: during hospitalization
ferritin
lab values of ferritin
Measured: during hospitalization
IL 6
lab values of IL6
Measured: during hospitalization
D dimers
lab vaules of D-dimers
Measured: during hospitalization
hepcidine
lab vaules of hepcidine
Measured: during hospitalization
ventilation
number of mechanical ventilation days (i.e., SIMV; SIPPV; HFOV etc) and/or CMO and number of days of ventilation in HFNC or CPAP
Measured: during hospitalization
adverse events
registration of adverse events
Measured: during hospitalization
pO2/FiO2
it is expected achieving a value of pO2/FiO2 > 350 in two consecutive determinations, limited to the subgroup of patients in which this ratio was <300 at the entrance and in presence of radiologically and clinically documented pneumonia
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start14 Jan 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized double-blind placebo- controlled designed trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paolo Manzoni
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Manzoni Study Group, Paolo Manzoni
- Investigators
- Paolo Manzoni, MD, Principal investigator, ASL BI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847791
- Sponsor's protocol ID
- 2020/279
- Acronym
- LAC
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andersen JH, Jenssen H, Sandvik K, Gutteberg TJ. Anti-HSV activity of lactoferrin and lactoferricin is dependent on the presence of heparan sulphate at the cell surface. J Med Virol. 2004 Oct;74(2):262-71. doi: 10.1002/jmv.20171.
PubMed 15332275Avula A, Nalleballe K, Narula N, Sapozhnikov S, Dandu V, Toom S, Glaser A, Elsayegh D. COVID-19 presenting as stroke. Brain Behav Immun. 2020 Jul;87:115-119. doi: 10.1016/j.bbi.2020.04.077. Epub 2020 Apr 28.
PubMed 32360439Yang Z, Jiang R, Chen Q, Wang J, Duan Y, Pang X, Jiang S, Bi Y, Zhang H, Lonnerdal B, Lai J, Yin S. Concentration of Lactoferrin in Human Milk and Its Variation during Lactation in Different Chinese Populations. Nutrients. 2018 Sep 5;10(9):1235. doi: 10.3390/nu10091235.
PubMed 30189612Wang Y, Wang P, Wang H, Luo Y, Wan L, Jiang M, Chu Y. Lactoferrin for the treatment of COVID-19 (Review). Exp Ther Med. 2020 Dec;20(6):272. doi: 10.3892/etm.2020.9402. Epub 2020 Oct 27.
PubMed 33199997Wakabayashi H, Oda H, Yamauchi K, Abe F. Lactoferrin for prevention of common viral infections. J Infect Chemother. 2014 Nov;20(11):666-71. doi: 10.1016/j.jiac.2014.08.003. Epub 2014 Aug 30.
PubMed 25182867
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactoferrin for Treatment of Acute COVID-19 Infection in Hospitalized Patients: a Double-blind Multicenter Placebo-controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT04847791
- Acronym / sponsor ID
- LAC / 2020/279
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Paolo ManzoniUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Apr 2021 (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.
TRIAL LAC is a randomized double-blind non profit multicenter study with a nutritional product: bovine lactoferrin - Mosiac 200 mg.
the hypothesis to be confirmed is that bovine LF, administered daily orally in addition to standard therapies for 1 month to hospitalized patients with Covid-19 infection, can be useful to limit the severity, progression of the disease, shorten the time of swabs negativization (i.e. time required to eliminate the virus) and to reduce the morbidity load associated with it.
Patient recruitment will involve 2 centers in Italy: Ospedale degli Infermi (Ponderano, Biella) and AOU Maggiore della Carità (Novara).
The subjects enrolled will be randomized to two Groups:
Group A (experimental arm) - Standard Anti-Covid-19 Therapy + Oral Administration of Bovine Lactoferrin (fixed dose 800 mg / day) for 30 days Group B (control arm) - Standard anti-Covid-19 therapy + Placebo administration (identical capsule with the same amount as an inert compound, starch of corn powder), according to the same pattern of use.
It should be specified that the study treatment and placebo will be administered in addition to the standard care in place, and therefore in addition to all the pharmacological treatments currently used in clinical hospital practice against Covid-19.
Detailed description
It has been shown with 'in vitro' studies that LF is able to prevent the entry of SARS-CoV-2 into the of the host cells.
Overall, the available evidence suggests that LF may be a therapeutic option that can be used to counteract and reduce the severity of Covid 19 infection. The study hase been designed in order to demonstrate efficacy of Lactoferrin in vivo.
Patients who will be admitted by Participating Centers for Covid-19 Infection will be screened for eligibility for study . If considered eligible, they will be offered participation in the Study, and it will be proposed and informed consent will be explained. Eligible patients will be registered in a centralized database at the IT systems of the University of Piedmont Orientale (UPO)/Hospital-University Company "Maggiore della Carità" of Novara. The pseudo-anonymized patient data will be recorded by the clinical centre in an 'ad hoc' Clinical Report Form with web-based access.
After obtaining informed consent, patients will then be randomised to LF or placebo group allocation using previous randomization lists Prepared. Randomization will take place on a competitive and balanced basis per clinical center participant. Permuted block randomization of size 4 will be implemented with an allocation ratio of 1:1 to ensure the balance between the groups of treatment. The randomization list will be managed through a REDCap randomization module.
The Hospital Pharmacy of the Participating Center, not involved in the enlistment of patients, will prepare a numbered sequence of sealed envelopes containing the code of allocation, and will keep its list that will remain inaccessible to the professionals involved in recruitment.These sealed envelopes will be opened sequentially, at the time of randomization.
The maintenance of the blind person will be guaranteed by keeping the staff randomization lists, i.e. the staff of the Hospital Pharmacy, on the one hand (staff who will also manage and deliver to the investigators the products being studied, which will look the same), and the randomizing and experimenting medical staff, on the other.
The logistical location of the two staff will also be completely separated, in sectors of the Hospital different and distant from each other, and not communicating in any way.
It should be pointed out that the patient enrolled by the clinical centers on the basis of the selection criteria can start standard-of-care therapy, in any case, before the randomization procedure being the identical basic therapeutic regimen in the two study arms.
For the calculation of the sample size required to demonstrate the primary endpoint, it was used a model built on historical data regarding the same endpoint. Pre-trial data from the two Participating Centres estimate the need for ICU admission at 25%; the need for mechanical ventilation in 30%; hospital mortality in 15%; the average duration hospitalization in 16 days.
The sample size was determined considering a two-sided t-test for two independent samples according to the following parameters:
- A correct alpha level of 0.025 for two Bonferroni-method endpoints (Alpha total=0.025x2=0.05)
- A total power of 0.8
- A Cohen h effect size of 0.44 (corresponding to an effect standardized medium/small [Cohen 1977]), i.e. with a 14-day resignation rate of 60% for controls and 80% for treaties.
In this scenario, the size of the study achieved consists of 97 patients per arm of study. Calculations were performed using the R 3.6.1 software [Core Team 2015] and the pwr package [Champely 2018]. references:
- Cohen, J. Statistical power analysis for the behavioral sciences (rev.ed.1977).
- Core Team R: A Language and Environment for Statistical Computing; R Foundation for Statistical Computing: Vienna, Austria, 2015;
- Champely, S.; Ekstrom, C.; Dalgaard, P.; Gill, J.; Weibelzahl, S.; Anandkumar, A.;Ford, C.; Volcic, R.; De Rosario, H.; De Rosario, M.H. Package 'pwr.' R package version 2018, 1-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized double-blind placebo- controlled designed trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: Bovine lactoferrinStandard Anti-Covid-19 Therapy + Oral Administration of Bovine Lactoferrin 400mg (two capsules of Mosiac 200 product) every 12 h (i.e., fixed dose 800 mg / day) for 30 days and still away from meals |
| Group B | Placebo comparator | Dietary Supplement: Placebo administrationStandard anti-Covid-19 therapy + Placebo administration (capsule identical with the same amount as an inert compound, starch of corn powder), according to the same pattern of use. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalization in non-ICU ward for Covid-19 infection, with virological diagnosis SARS-CoV2 confirmed via RT-PCR (or quick test)
- Age>18 aa
- Covid symptomatology story from no more than 12 days
Key exclusion criteria (5 listed)
- Refusal of consent
- Need for immediate admission to intensive care
- Severe neoplasms (in advanced stage)
- Allergies or intolerances known to Lactoferrin
- 4. Already being treated with Lactoferrin at the entrance to the Hospital 5. Patients with end-stage renal failure (stage 5) 6. Extremely serious general conditions to suggest an imminent exitus 7. Clinical conditions of absolute impossibility of tolerating ingestion of drugs/capsules due to conditions contraining the initiation of therapy for os.
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 |
|---|---|---|
| Bovine lactoferrinAlso: MOSIACOral Administration of Bovine Lactoferrin -fixed dose 800 mg / day for 30 days | Dietary supplement | Group A |
| Placebo administrationcapsule identical with the same amount as an inert compound, starch of corn powder), according to the same pattern of use. | Dietary supplement | Group B |
Primary outcome
intensive care unit hospitalization rate
Time frame: 1 year
The primary endpoint will be to evaluate the efficacy of bovine LF orally (BLF- Mosiac) compared to placebo in affecting at least one of the following: 1) it is expected a reduction of a composite event rate consisting of two items: the number of hospitalizations in intensive care unit due to any cause and the number of deaths
death
Time frame: 1 year
number of deaths during hospitalization
proportion of discharged patients
Time frame: 1 year
The primary endpoint will be to evaluate the efficacy of bovine LF orally (BLF- Mosiac) compared to placebo in affecting at least one of the following: 2) it is expected an increase of proportion of discharged patients within 14 days and an increase of number of patients reaching a National Early Warning Score (NEWS) of 2 or less
National Early Warning Score (NEWS)
Time frame: during hospitalization
it is expected an increase of number of patients reaching a National Early Warning Score (NEWS) of 2 or less, maintained for at least 24hrs
9 secondary outcomes
daily clinical severity score
Time frame: during hospitalization
oxygen
Time frame: during hospitalization
ferritin
Time frame: during hospitalization
IL 6
Time frame: during hospitalization
D dimers
Time frame: during hospitalization
hepcidine
Time frame: during hospitalization
ventilation
Time frame: during hospitalization
adverse events
Time frame: during hospitalization
pO2/FiO2
Time frame: during hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Background: PubMed 15332275Andersen JH, Jenssen H, Sandvik K, Gutteberg TJ. Anti-HSV activity of lactoferrin and lactoferricin is dependent on the presence of heparan sulphate at the cell surface. J Med Virol. 2004 Oct;74(2):262-71. doi: 10.1002/jmv.20171.
- Background: PubMed 32360439Avula A, Nalleballe K, Narula N, Sapozhnikov S, Dandu V, Toom S, Glaser A, Elsayegh D. COVID-19 presenting as stroke. Brain Behav Immun. 2020 Jul;87:115-119. doi: 10.1016/j.bbi.2020.04.077. Epub 2020 Apr 28.
- Background: PubMed 30189612Yang Z, Jiang R, Chen Q, Wang J, Duan Y, Pang X, Jiang S, Bi Y, Zhang H, Lonnerdal B, Lai J, Yin S. Concentration of Lactoferrin in Human Milk and Its Variation during Lactation in Different Chinese Populations. Nutrients. 2018 Sep 5;10(9):1235. doi: 10.3390/nu10091235.
- Background: PubMed 33199997Wang Y, Wang P, Wang H, Luo Y, Wan L, Jiang M, Chu Y. Lactoferrin for the treatment of COVID-19 (Review). Exp Ther Med. 2020 Dec;20(6):272. doi: 10.3892/etm.2020.9402. Epub 2020 Oct 27.
- Background: PubMed 25182867Wakabayashi H, Oda H, Yamauchi K, Abe F. Lactoferrin for prevention of common viral infections. J Infect Chemother. 2014 Nov;20(11):666-71. doi: 10.1016/j.jiac.2014.08.003. Epub 2014 Aug 30.
- Individual participant dataSharing planned: No
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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.
Paolo Manzoni, MD principal investigator
ASL BI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bovine lactoferrin in people with Covid19, run by Paolo Manzoni at 2 sites in Italy.
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 3 inclusion and 5 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 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Manzoni, MD (00390151515 ext. 7626, paolomanzoni@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intensive care unit hospitalization rate (time frame: 1 year). 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 NCT04847791, which also lists 5 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 19 Apr 2021.