AzTrials
AzTrials

COVID-19 Virus DiseasePhase 2COVID-19NCT05305508

Assessment of the Efficacy of Calcium Dobesilate vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.

A Phase 2 study testing Calcium Dobesilate and Mannitol in people with COVID-19 Virus Disease, run by Hervé SPECHBACH at 1 site in Switzerland.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of CaD in reducing SARS-CoV-2 viral load in non-hospitalized adult patients diagnosed with COVID-19, documented with a positive SARS-CoV-2 PCR and with the occurrence of COVID-19 symptoms. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
COVID-19 Virus Disease
What is being tested?
Calcium Dobesilate and Mannitol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
1 siteSwitzerland
Study dates
17 May 2022to 5 Feb 2024
Phase
Phase 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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Documented COVID-19 diagnosis (SARS-CoV-2 positivity as assessed by PCR) ≤3 days of symptom appearance, with a CT<25.
  • Symptoms related to Day 1 ≤ 5 days.
  • Participant presents at least one of the following acute COVID-19 symptoms: nasal congestion or runny nose, sore throat, headache, myalgia, dry/productive cough, fever, chills, abdominal symptoms (nausea, vomiting, diarrhea, abdominal pain), fatigue, chest pain, palpitations, and shortness of breath.
  • Participant is aged ≥ 16 years of age.
  • Participant has provided an appropriate signed Informed consent.

Who cannot join

  • Known hypersensitivity or allergy to any of the study products to be administered.
  • Participation in any other investigational device or drug study within 30 days preceding study screening visit.
  • Treatment with Calcium Dobesilate or related molecules (e.g., ethamsylate) within 30 days preceding screening visit, or current treatment with any other investigational agent(s).
  • Breastfeeding, unless If the patient agrees to stop breastfeeding
  • Treatment with any investigational, emergency use authorization-approved, or approved drug for COVID-19, such as, but not limited to: monoclonal antibody treatment, direct or indirect antiviral treatment, and others according to local guidelines.
  • Any kind of disorder or medical conditions that, in the opinion of the investigators, may be associated with increased risk to the participant, may affect patients' compliance, or may interfere with study assessments or outcomes.
Show all 9Show fewer
  • Inability to follow and comply with study procedures.
  • Participant has hospitalization criteria according to local guidelines (Sat < 95%, RR >25) at the time of screening or is admitted to hospital prior to randomization
  • Participant is, in the opinion of the investigators, likely to deteriorate in the next 24-48h and require hospitalization

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Division and Department of Primary Care Medicine, Geneva University Hospitals

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: A Randomized, Placebo-controlled, Double-blind, Monocenter, Phase II Trial to Assess the Efficacy of Calcium Dobesilate (CaD) vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.

The purpose of this study is to evaluate the efficacy and safety of CaD in reducing SARS-CoV-2 viral load in non-hospitalized adult patients diagnosed with COVID-19, documented with a positive SARS-CoV-2 PCR and with the occurrence of COVID-19 symptoms.

Read the detailed description

This study is a phase II, randomized, double-blind, placebo-controlled, monocenter trial. The study will assess the efficacy and safety of CaD compared to placebo in reducing SARS-CoV-2 viral load in non-hospitalized adult patients diagnosed with COVID-19, as well as monitoring symptoms severity, progression of the disease to severe form, and persistence of symptoms.

The treatment period is seven consecutive days, followed by a 12-weeks observational period without treatment administration.

Enrolled patients will be randomized, in a ratio of 1:1 into the following treatment groups: - IMP arm: patients will receive 2 x 2 capsules of Calcium Dobesilate (CaD) 500 mg (total of 2000 mg) daily for seven consecutive days

  • Placebo arm: patients will receive 2 x 2 capsules of matching placebo (Mannitol 500 mg) daily for seven consecutive days.
Being tested
Calcium Dobesilate, Mannitol
Keywords
Calcium Dobesilate, Viral load, COVID-19 symptoms
Medical subject headings
COVID-19

What participants receive

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

  • Calcium DobesilateDrug

    Also called DOXIUM 500, OM Pharma

    The treatment (CaD, Calcium Dobesilate 500 mg) will be administered orally twice a day for 7 days.

  • MannitolDrug

    Also called Placebo

    The comparator (placebo, Mannitol 500 mg) will be administered orally twice a day for 7 days.

Study groups in NCT05305508
Study groupRoleWhat they receive
placeboPlacebo comparatorThe comparator (placebo, Mannitol 500 mg) will be administered orally twice a day for 7 days.
Receives: Drug: Mannitol
Calcium DobesilateExperimentalThe CaD (Calcium Dobesilate 500 mg) will be administered orally twice a day for 7 days.
Receives: Drug: Calcium Dobesilate

What is being measured

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

  1. Primary Outcome

    Reduction from baseline of RT-PCR SARS-CoV-2 viral load at day 4, defined by Polymerase Chain Reaction (PCR) threshold cycles. PCR reaction happens in cycles of amplification. Inclusion criteria to enter in the study is a RT-PCR positive for SARS-CoV-2, which correspond to 25 cycles (or lower) of the RT-PCR test. The participant will be tested at day 4 after treatment to evaluate if the viral load has decreased. To do that, another RT-PCR SARS-CoV-2 will be performed. A higher value of RT-PCR cycles compared to the one obtained when the participat was diagnosed COVID-19 positive, is considered a reduction from baseline.

    Measured: baseline and day 4

Secondary outcomes (6)

  1. SARS-CoV-2 Viral Load at day 8

    Reduction from baseline of RT-PCR SARS-CoV-2 viral load at day 8.

    Measured: baseline and day 8

  2. SARS-CoV-2 Viral Load negativity

    Proportion of patients with viral load negativity or very low viral load (defined by PCR threshold cycles >32) at days 4, 8 and 21.

    Measured: day 4, 8 and 21

  3. Symptoms

    Time to acute symptom resolution after randomisation to treatment.

    Proportion of participants with acute symptom resolution at days 4, 8, 21.

    Measured: day 4, 8 and 21

  4. Symptoms resolution

    Proportion of participants with acute symptom resolution at days 4, 8, 21.

    Measured: day 4, 8 and 21

  5. Persistent COVID-19 symptoms

    Proportion of patients with persistent symptoms (≥1 of the following symptoms: fatigue, headache, intermittent fever, palpitations/tachycardia, sleep disturbance, anxiety, blurred vision, depression, brain fog (difficulty concentrating), loss of memory, dizziness, tinnitus (and other hearing issues), altered smell, altered taste, shortness of breath, chest pain, cough, myalgia (and spasms), neuralgias, arthralgia (joint pain), paraesthesia, nausea, vomiting, diarrhea, constipation, abdominal pain, menstrual and period problems as well as new onset of allergies) at day 84 (week 12).

    Measured: day 84

  6. Mental and physical score

    SF12 score at day 21 and day 84 (week 12) compared to day 1 (baseline).

    Measured: baseline and 84

Timeline

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

  1. First posted31 Mar 2022
  2. Study start17 May 2022
  3. Primary completion10 Nov 2023
  4. Study completion5 Feb 2024

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05305508
Sponsor's protocol ID
2022-00000
Acronym
COVID-19
Status last verified
Feb 2024
First submitted
25 Mar 2022
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou Y, Yang Q, Chi J, Dong B, Lv W, Shen L, Wang Y. Comorbidities and the risk of severe or fatal outcomes associated with coronavirus disease 2019: A systematic review and meta-analysis. Int J Infect Dis. 2020 Oct;99:47-56. doi: 10.1016/j.ijid.2020.07.029. Epub 2020 Jul 25.

    PubMed 32721533

  • Guan WJ, Liang WH, Zhao Y, Liang HR, Chen ZS, Li YM, Liu XQ, Chen RC, Tang CL, Wang T, Ou CQ, Li L, Chen PY, Sang L, Wang W, Li JF, Li CC, Ou LM, Cheng B, Xiong S, Ni ZY, Xiang J, Hu Y, Liu L, Shan H, Lei CL, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Cheng LL, Ye F, Li SY, Zheng JP, Zhang NF, Zhong NS, He JX; China Medical Treatment Expert Group for COVID-19. Comorbidity and its impact on 1590 patients with COVID-19 in China: a nationwide analysis. Eur Respir J. 2020 May 14;55(5):2000547. doi: 10.1183/13993003.00547-2020. Print 2020 May.

    PubMed 32217650

  • Zaim S, Chong JH, Sankaranarayanan V, Harky A. COVID-19 and Multiorgan Response. Curr Probl Cardiol. 2020 Aug;45(8):100618. doi: 10.1016/j.cpcardiol.2020.100618. Epub 2020 Apr 28.

    PubMed 32439197

  • Amraei R, Rahimi N. COVID-19, Renin-Angiotensin System and Endothelial Dysfunction. Cells. 2020 Jul 9;9(7):1652. doi: 10.3390/cells9071652.

    PubMed 32660065

  • Suschek C, Kolb H, Kolb-Bachofen V. Dobesilate enhances endothelial nitric oxide synthase-activity in macro- and microvascular endothelial cells. Br J Pharmacol. 1997 Dec;122(7):1502-8. doi: 10.1038/sj.bjp.0701512.

    PubMed 9421302

  • Zhou Y, Yuan J, Qi C, Shao X, Mou S, Ni Z. Calcium dobesilate may alleviate diabetes-induced endothelial dysfunction and inflammation. Mol Med Rep. 2017 Dec;16(6):8635-8642. doi: 10.3892/mmr.2017.7740. Epub 2017 Oct 9.

    PubMed 29039485

  • Allain H, Ramelet AA, Polard E, Bentue-Ferrer D. Safety of calcium dobesilate in chronic venous disease, diabetic retinopathy and haemorrhoids. Drug Saf. 2004;27(9):649-60. doi: 10.2165/00002018-200427090-00003.

    PubMed 15230646

  • Rabe E, Ballarini S, Lehr L; Doxium EDX09/01 Study Group. A randomized, double-blind, placebo-controlled, clinical study on the efficacy and safety of calcium dobesilate in the treatment of chronic venous insufficiency. Phlebology. 2016 May;31(4):264-74. doi: 10.1177/0268355515586097. Epub 2015 May 18.

    PubMed 25991692

  • Liu J, Li S, Sun D. Calcium Dobesilate and Micro-vascular diseases. Life Sci. 2019 Mar 15;221:348-353. doi: 10.1016/j.lfs.2019.02.023. Epub 2019 Feb 12.

    PubMed 30769115

  • Fernandez IS, Cuevas P, Angulo J, Lopez-Navajas P, Canales-Mayordomo A, Gonzalez-Corrochano R, Lozano RM, Valverde S, Jimenez-Barbero J, Romero A, Gimenez-Gallego G. Gentisic acid, a compound associated with plant defense and a metabolite of aspirin, heads a new class of in vivo fibroblast growth factor inhibitors. J Biol Chem. 2010 Apr 9;285(15):11714-29. doi: 10.1074/jbc.M109.064618. Epub 2010 Feb 9.

    PubMed 20145243

  • Angulo J, Peiro C, Romacho T, Fernandez A, Cuevas B, Gonzalez-Corrochano R, Gimenez-Gallego G, de Tejada IS, Sanchez-Ferrer CF, Cuevas P. Inhibition of vascular endothelial growth factor (VEGF)-induced endothelial proliferation, arterial relaxation, vascular permeability and angiogenesis by dobesilate. Eur J Pharmacol. 2011 Sep 30;667(1-3):153-9. doi: 10.1016/j.ejphar.2011.06.015. Epub 2011 Jun 22.

    PubMed 21703259

  • Angulo J, Cuevas P, Cuevas B, El Youssef M, Fernandez A, Martinez-Salamanca E, Gonzalez-Corrochano R, Gimenez-Gallego G. Diacetyloxyl derivatization of the fibroblast growth factor inhibitor dobesilate enhances its anti-inflammatory, anti-angiogenic and anti-tumoral activities. J Transl Med. 2015 Feb 1;13:48. doi: 10.1186/s12967-015-0413-4.

    PubMed 25638171

  • Njau F, Shushakova N, Schenk H, Wulfmeyer VC, Bollin R, Menne J, Haller H. Calcium dobesilate reduces VEGF signaling by interfering with heparan sulfate binding site and protects from vascular complications in diabetic mice. PLoS One. 2020 Jan 14;15(1):e0218494. doi: 10.1371/journal.pone.0218494. eCollection 2020.

    PubMed 31935212

  • Yin XX, Zheng XR, Peng W, Wu ML, Mao XY. Vascular Endothelial Growth Factor (VEGF) as a Vital Target for Brain Inflammation during the COVID-19 Outbreak. ACS Chem Neurosci. 2020 Jun 17;11(12):1704-1705. doi: 10.1021/acschemneuro.0c00294. Epub 2020 Jun 2.

    PubMed 32485101

  • Clausen TM, Sandoval DR, Spliid CB, Pihl J, Perrett HR, Painter CD, Narayanan A, Majowicz SA, Kwong EM, McVicar RN, Thacker BE, Glass CA, Yang Z, Torres JL, Golden GJ, Bartels PL, Porell RN, Garretson AF, Laubach L, Feldman J, Yin X, Pu Y, Hauser BM, Caradonna TM, Kellman BP, Martino C, Gordts PLSM, Chanda SK, Schmidt AG, Godula K, Leibel SL, Jose J, Corbett KD, Ward AB, Carlin AF, Esko JD. SARS-CoV-2 Infection Depends on Cellular Heparan Sulfate and ACE2. Cell. 2020 Nov 12;183(4):1043-1057.e15. doi: 10.1016/j.cell.2020.09.033. Epub 2020 Sep 14.

    PubMed 32970989

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Calcium Dobesilate and Mannitol in people with COVID-19 Virus Disease, run by Hervé SPECHBACH at 1 site in Switzerland.

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 5 inclusion and 9 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 28 Feb 2024. 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 Switzerland. 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 phase mean?

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 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?

Primary Outcome (time frame: baseline and day 4). 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 NCT05305508, which also lists 20 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 28 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in