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InfectionsOnCOVInfNCT05080920

Rosmalip® for Cancer Infections Prevention

A study testing Rosmalip® in people with Infections and Covid19, run by Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares at 1 site in Spain.

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

This study is designed to assess the safety and efficacy of Rosmalip® nutritional supplement compared to placebo in subjects with solid cancer for the prevention of infections including COVID-19. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Infections, Covid19, Cancer
What is being tested?
Rosmalip®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
109 participants
Where
1 siteSpain
Study dates
28 Oct 2020to 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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a solid cancer under active Anticancer Treatment (including Chemotherapy, Immunotherapy, Hormone Therapy, Targeted Therapy)
  • Informed consent signature

Who cannot join

  • Allergies to fish
  • Vitamin, Antioxidants consumers and who would no accept to stop taking them 1 week before and during the study
  • Disphagia
  • Bilirrubin higher than 1.5 Upper Normal Limit (UNL)/ Creatinin > 1.5 UNL
  • Severe organic dysfunction
  • Cardiac dysfunction
Show all 11Show fewer
  • Cholangitis/ Biliary tract obstruction
  • Immunodeficiency or Immflamatory disease (HIV, Inflammatory Bowel Disease, Collagenosis)
  • Dementia or Psychiatric severe disease
  • Pregnancy or Breastfeeding
  • Previous diseases that interfere lipid carrier absorption

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Servicio de Oncología. Hospital Infanta Sofía.

    San Sebastián de los Reyes, Madrid, 28134

Other trials in Spain

About this study

Official title: A Pilot, Randomized, Double Blind, Placebo Controlled Study to Evaluate an Immune System Modulator Nutritional Supplement for the Prevention of Infections in Cancer Patients Receiving Oncologic Treatment During the COVID-19 Pandemia.

This study is designed to assess the safety and efficacy of Rosmalip® nutritional supplement compared to placebo in subjects with solid cancer for the prevention of infections including COVID-19.

Read the detailed description

Cancer patients undergoing oncologic treatments frequently have comorbidities and suffer immunosuppresion, toxicities and exposure to nosocomial pathogens. As a result, they are at increased risk of infections, including COVID-19. It is of utmost importance to find therapies that can prevent infections with as less toxicity as possible. Rosmalip® is a nutritional supplement developed as a molecular nutrition, composed of a rosemary supercritical extract at concentrations approved by EFSA -with in vitro and in vivo antitumor effects that are independent of its antioxidant and anti-inflammatory properties- in a lipidic vehicle that has shown in preclinical and clinical studies to potentiate innate immunity without apparent toxicity. Being a product of easy synthesis its effects on immunity, inflammation and cancer, could be of interest to prevent and ameliorate infections, including COVID-19.

In this pilot study it is hypothesized that Rosmalip® could help to prevent or ameliorate infections, including COVID-19, in oncologic patients under active treatment. Secondarily, it is also hypothesized to have metabolic beneficial effects.

Being tested
Rosmalip®, Placebo
Medical subject headings
Infections, COVID-19, Neoplasms

What participants receive

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

  • Rosmalip®Dietary supplement

    Nutritional Supplement+Usual Care

  • PlaceboOther

    Placebo+Usual Care

Study groups in NCT05080920
Study groupRoleWhat they receive
Rosmalip®ExperimentalParticipants receive Rosmalip® (diterpene phenols 11,25 mg) 1 capsule orally once daily for 16 weeks
Receives: Dietary Supplement: Rosmalip®
PlaceboPlacebo comparatorParticipants receive Placebo 1 capsule matching Rosmalip® orally once daily for 16 weeks
Receives: Other: Placebo

What is being measured

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

  1. Number of infectious events

    Number of infectious events according to International Sepsis Forum Consensus

    Measured: 6 months

Secondary outcomes (8)

  1. Number of SARSCoV2 infections

    Number of PCR confirmed SARSCoV2 infections

    Measured: 6 months

  2. Changes in NLR (neutrophils to lymphocytes ratio).

    Evolution of inflammatory markers

    Measured: 6 months

  3. Changes in C-reactive protein

    Evolution of inflammatory markers

    Measured: 6 months

  4. Changes in ferritin

    Evolution of inflammatory markers

    Measured: 6 months

  5. Changes in transferrin

    Evolution of inflammatory markers

    Measured: 6 months

  6. Changes in number of peripheral blood mononuclear cells

    Evolution of immune profile

    Measured: 6 months

  7. Changes in number of CD4 and CD8 lymphocyte populations

    Evolution of immune profile

    Measured: 6 months

  8. Evolution of Quality of life

    Changes is quality of life according to the SF-36 (Short Form Health Survey) questionnaire. The score values goes from 0 to 100 and higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.

    Measured: 6 months

Timeline

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

  1. First posted18 Oct 2021
  2. Study start28 Oct 2020
  3. Primary completion30 Sep 2022
  4. Study completion31 Dec 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants receive Rosmalip® capsule or Placebo tablet matching Rosmalip® orally once daily for 16 weeks.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05080920
Sponsor's protocol ID
Rosmalip®-OnCOVInf
Acronym
OnCOVInf
Status last verified
Sep 2023
First submitted
16 Oct 2020
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mouhid L, Corzo-Martinez M, Torres C, Vazquez L, Reglero G, Fornari T, Ramirez de Molina A. Improving In Vivo Efficacy of Bioactive Molecules: An Overview of Potentially Antitumor Phytochemicals and Currently Available Lipid-Based Delivery Systems. J Oncol. 2017;2017:7351976. doi: 10.1155/2017/7351976. Epub 2017 May 7.

    PubMed 28555156

  • Gomez de Cedron M, Laparra JM, Loria-Kohen V, Molina S, Moreno-Rubio J, Montoya JJ, Torres C, Casado E, Reglero G, Ramirez de Molina A. Tolerability and Safety of a Nutritional Supplement with Potential as Adjuvant in Colorectal Cancer Therapy: A Randomized Trial in Healthy Volunteers. Nutrients. 2019 Aug 24;11(9):2001. doi: 10.3390/nu11092001.

    PubMed 31450563

  • Gonzalez-Vallinas M, Reglero G, Ramirez de Molina A. Rosemary (Rosmarinus officinalis L.) Extract as a Potential Complementary Agent in Anticancer Therapy. Nutr Cancer. 2015;67(8):1221-9. doi: 10.1080/01635581.2015.1082110. Epub 2015 Oct 9.

    PubMed 26452641

  • Gonzalez-Vallinas M, Molina S, Vicente G, Sanchez-Martinez R, Vargas T, Garcia-Risco MR, Fornari T, Reglero G, Ramirez de Molina A. Modulation of estrogen and epidermal growth factor receptors by rosemary extract in breast cancer cells. Electrophoresis. 2014 Jun;35(11):1719-27. doi: 10.1002/elps.201400011. Epub 2014 Mar 20.

    PubMed 24615943

  • Gonzalez-Vallinas M, Molina S, Vicente G, Zarza V, Martin-Hernandez R, Garcia-Risco MR, Fornari T, Reglero G, Ramirez de Molina A. Expression of microRNA-15b and the glycosyltransferase GCNT3 correlates with antitumor efficacy of Rosemary diterpenes in colon and pancreatic cancer. PLoS One. 2014 Jun 3;9(6):e98556. doi: 10.1371/journal.pone.0098556. eCollection 2014.

    PubMed 24892299

  • Gonzalez-Vallinas M, Molina S, Vicente G, de la Cueva A, Vargas T, Santoyo S, Garcia-Risco MR, Fornari T, Reglero G, Ramirez de Molina A. Antitumor effect of 5-fluorouracil is enhanced by rosemary extract in both drug sensitive and resistant colon cancer cells. Pharmacol Res. 2013 Jun;72:61-8. doi: 10.1016/j.phrs.2013.03.010. Epub 2013 Apr 1.

    PubMed 23557932

  • Gomez de Cedron M, Moreno-Rubio J, de la O Pascual V, Alvarez B, Villarino M, Sereno M, Gomez-Raposo C, Roa S, Lopez Gomez M, Merino-Salvador M, Jimenez-Gordo A, Falagan S, Aguayo C, Zambrana F, Tabares B, Garrido B, Cruz-Gil S, Fernandez Diaz CM, Fernandez LP, Molina S, Crespo MC, Ouahid Y, Montoya JJ, Ramos Ruiz R, Reglero G, Ramirez de Molina A, Casado E. Randomized clinical trial in cancer patients shows immune metabolic effects exerted by formulated bioactive phenolic diterpenes with potential clinical benefits. Front Immunol. 2025 Feb 17;16:1519978. doi: 10.3389/fimmu.2025.1519978. eCollection 2025.

    PubMed 40034703

  • Bouzas A, Gomez de Cedron M, Colmenarejo G, Laparra-Llopis JM, Moreno-Rubio J, Montoya JJ, Reglero G, Casado E, Tabares B, Sereno M, Ramirez de Molina A. Phenolic diterpenes from Rosemary supercritical extract inhibit non-small cell lung cancer lipid metabolism and synergise with therapeutic drugs in the clinic. Front Oncol. 2022 Nov 9;12:1046369. doi: 10.3389/fonc.2022.1046369. eCollection 2022.

    PubMed 36439419

Questions about this trial

What is this clinical trial studying?

A study testing Rosmalip® in people with Infections and Covid19, run by Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares at 1 site in Spain.

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 2 inclusion and 11 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 21 Sep 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 Spain. 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?

Number of infectious events (time frame: 6 months). 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 NCT05080920, which also lists 8 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 21 Sep 2023.

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