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Covid19ACTIVNCT04492384

Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients

An observational study of Covid19 and SARS-CoV-2 Infection, run by Eurasian Association of Therapists at 1 site in Russia.

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

Non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 infection in adults. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19, SARS-CoV-2 Infection, Pneumonia
What is being tested?
non-interventional
How many people
6,396 participants
Where
1 siteRussia
Study dates
29 Jun 2020to 29 Nov 2021
Phase
Observational
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
  • Adult, Older adult

Study population: Anonymized male and female patients over 18 years infected COVID-19 recieved inpatient or outpatient care

Who may be able to join

  • Suspected or confirmed COVID-19.

Who cannot join

  • Refuse to be involved in study;
  • Age under 18 years.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Eurasian Association of Therapists

    Moscow, 101000

Other trials in Russia

About this study

Non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 infection in adults.

Read the detailed description

Non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 infection in cohort of Russian adult patients.

Retrospective analysis of medical histories and outcomes in adults with pre-existing conditions after SARS-CoV-2 infection and prospective monitoring of health status during 3, 6 and 12 months after discharge. Comorbidities worsening risk factors measuring through evaluation of range of indicators such as dynamics of diabetes, CKD, COPD, bronchial astma, incidence of hypertonic crises, vascular events and others.

Being tested
non-interventional
Medical subject headings
COVID-19, Pneumonia, Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases, Overweight, Obesity, Diabetes Mellitus, Hypertension

What participants receive

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

  • non-interventionalOther

    Interview on health conditions

Study groups in NCT04492384
Study groupRoleWhat they receive
inpatientsPatients treated from COVID-19 in hospital
Receives: Other: non-interventional
outpatientsPatients treated from COVID-19 at home
Receives: Other: non-interventional

What is being measured

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

  1. rate of non-infectious diseases

    percentage of patients with non-infectious diseases relating to overall number of patients registered in study

    Measured: 12 month since a moment of request of medical help

  2. severity of COVID-19 depending on pre-existing diseases

    correlation between number of patients with COVID-19 of various severity and number of pre-existing conditions and their severity among these groups

    Measured: 12 month since a moment of request of medical help

  3. disability registration / change of disability status

    Registration of disability or change of disability status

    Measured: 12 month since a moment of request of medical help

  4. rate of letal outcomes

    rate of deaths among registered participants

    Measured: 12 month since a moment of request of medical help

  5. rate of letal outcomes depending on pre-existing disease

    correlation between number of deaths and pre-existing diseases

    Measured: 12 month since a moment of request of medical help

Timeline

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

  1. First posted30 Jul 2020
  2. Study start29 Jun 2020
  3. Primary completion29 Nov 2020
  4. Study completion29 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
6,396 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04492384
Sponsor's protocol ID
ACTIV11062020
Acronym
ACTIV
Status last verified
Sep 2023
First submitted
27 Jul 2020
Last updated
8 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shchepikhin EI, Shmelev EI, Ergeshov AE. [Pulmonary fibrosis after a new coronavirus infection - versions and controversies: A review]. Ter Arkh. 2024 Apr 16;96(3):298-302. doi: 10.26442/00403660.2024.03.202632. Russian.

    PubMed 38713047

  • Arutyunov GP, Tarlovskaya EI, Arutyunov AG, Belenkov YN, Konradi AO, Lopatin YM, Rebrov AP, Tereshchenko SN, Chesnikova AI, Hayrapetyan HG, Babin AP, Bakulin IG, Bakulina NV, Balykova LA, Blagonravova AS, Boldina MV, Vaisberg AR, Galyavich AS, Gomonova VV, Grigorieva NY, Gubareva IV, Demko IV, Evzerikhina AV, Zharkov AV, Kamilova UK, Kim ZF, Kuznetsova TY, Lareva NV, Makarova EV, Malchikova SV, Nedogoda SV, Petrova MM, Pochinka IG, Protasov KV, Protsenko DN, Ruzanau DY, Sayganov SA, Sarybaev AS, Selezneva NM, Sugraliev AB, Fomin IV, Khlynova OV, Chizhova OY, Shaposhnik II, Sh'ukarev DA, Abdrahmanova capital A, CyrillicK, Avetisian SA, Avoyan HG, Azarian KK, Aimakhanova GT, Ayipova DA, Akunov AC, Alieva MK, Aparkina AV, Aruslanova OR, Ashina EY, Badina OY, Barisheva OY, Batchayeva AS, Bitieva AM, Bikhteyev IU, Borodulina NA, Bragin MV, Budu AM, Bykova GM, Vagapova KR, Varlamova DD, Vezikova NN, Verbitskaya EA, Vilkova OE, Vinnikova EA, Vustina VV, Galova EA, Genkel VV, Gorshenina EI, Gostishev RV, Grigorieva EV, Gubareva EY, Dabylova GM, Demchenko AI, Dolgikh OY, Duyshobayev MY, Evdokimov DS, Egorova KE, Ermilova AN, Zheldybayeva AE, Zarechnova NV, Zimina YD, Ivanova SY, Ivanchenko EY, Ilina MV, Kazakovtseva MV, Kazymova EV, Kalinina YS, Kamardina NA, Karachenova AM, Karetnikov IA, Karoli NA, Karsiev MK, capital KA, Cyrillicaskaeva DS, Kasymova KF, Kerimbekova ZB, Kerimova AS, Kim ES, Kiseleva NV, Klimenko DA, Klimova AV, Kovalishena OV, Kolmakova EV, Kolchinskaya TP, Kolyadich MI, Kondriakova OV, Konoval MP, Konstantinov DY, Konstantinova EA, Kordukova VA, Koroleva EV, Kraposhina AY, Kriukova TV, Kuznetsova AS, Kuzmina TY, Kuzmichev KV, Kulchoroevna CK, Kuprina TV, Kouranova IM, Kurenkova LV, Kurchugina NY, Kushubakova NA, Levankova VI, Lyubavina NA, Magdeyeva NA, Mazalov KV, Majseenko VI, Makarova AS, Maripov AM, Marusina AA, Melnikov ES, Moiseenko NB, Muradova FN, Muradyan RG, Musaelian SN, Myshak AO, Nekaeva ES, Nikitina NM, Ogurlieva BB, Odegova AA, Omarova YV, Omurzakova NA, Ospanova SO, Pahomova EV, Petrov LD, Plastinina SS, Pogrebetskaya VA, Polyakov DS, Ponomarenko EV, Popova LL, Prokofeva NA, Pudova IA, Rakov NA, Rahimov AN, Rozanova NA, Serikbolkyzy S, Simonov AA, Skachkova VV, Soloveva DV, Soloveva IA, Subbotin AK, Sukhomlinova IM, Sushilova AG, Tagayeva DR, Titojkina YV, Tikhonova EP, Tokmin DS, Tolmacheva AA, Torgunakova MS, Trenogina KV, Trostianetckaia NA, Trofimov DA, Tulichev AA, Tursunova AT, Ulanova ND, Fatenkov OV, Fedorishina OV, Fil TS, Fomina IY, Fominova IS, Frolova IA, Tsvinger SM, Tsoma VV, Cholponbaeva MB, Chudinovskikh TI, Shevchenko OA, Sheshina TV, Shishkina EA, Shishkov KY, Sherbakov SY, Yausheva EA. [ACTIV SARS-CoV-2 registry (Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients). Assessment of impact of combined original comorbid diseases in patients with COVID-19 on the prognosis]. Ter Arkh. 2022 Jan 15;94(1):32-47. doi: 10.26442/00403660.2022.01.201320. Russian.

    PubMed 36286918

  • Tarlovskaya EI, Arutyunov AG, Konradi AO, Lopatin YM, Rebrov AP, Tereshchenko SN, Chesnikova AI, Hayrapetyan HG, Babin AP, Bakulin IG, Bakulina NV, Balykova LA, Blagonravova AS, Boldina MV, Vaisberg AR, Galyavich AS, Gomonova VV, Grigorieva NY, Gubareva IV, Demko IV, Evzerikhina AV, Zharkov AV, Kamilova UK, Kim ZF, Kuznetsova TY, Lareva NV, Makarova EV, Malchikova SV, Nedogoda SV, Petrova MM, Pochinka IG, Protasov KV, Protsenko DN, Ruzanau DY, Sayganov SA, Sarybaev AS, Selezneva NM, Sugraliev AB, Fomin IV, Khlynova OV, Chizhova OY, Shaposhnik II, Shsmall es, Cyrillicukarev DA, Abdrahmanova AK, Avetisian SA, Avoyan HG, Azarian KK, Aimakhanova GT, Ayipova DA, Akunov AC, Alieva MK, Aparkina AV, Aruslanova OR, Ashina EY, Badina OY, Barisheva OY, Batchayeva AS, Bitieva AM, Bikhteyev IU, Borodulina NA, Bragin MV, Budu AM, Burygina LA, Bykova GA, Vagapova KR, Varlamova DD, Vezikova NN, Verbitskaya EA, Vilkova OE, Vinnikova EA, Vustina VV, Gsmall a, Cyrilliclova EA, Genkel VV, Gorshenina EI, Gostishev RV, Grigorieva EV, Gubareva EY, Dabylova GM, Demchenko AI, Dolgikh OY, Duyshobayev MY, Evdokimov DS, Egorova KE, Ermilova AN, Zheldybayeva AE, Zarechnova NV, Zimina YD, Ivanova SY, Ivanchenko EY, Ilina MV, Kazakovtseva MV, Kazymova EV, Kalinina YS, Kamardina NA, Karachenova AM, Karetnikov IA, Karoli NA, Karpov OV, Karsiev MK, capital KA, Cyrillicaskaeva DS, Kasymova KF, Kerimbekova ZB, Kerimova AS, Kim ES, Kiseleva NV, Klimenko DA, Klimova AV, Kovalishena OV, Kolmakova EV, Kolchinskaya TP, Kolyadich MI, Kondriakova OV, Konoval MP, Konstantinov DY, Konstantinova EA, Kordukova VA, Koroleva EV, Kraposhina AY, Kriukova TV, Kuznetsova AS, Kuzmina TY, Kuzmichev KV, Kulchoroeva CK, Kuprina TV, Kouranova IM, Kurenkova LV, Kurchugina NY, Kushubakova NA, Levankova VI, Levin Mcapital IE, Cyrillic, Lyubavina NA, Magdeyeva NA, Mazalov KV, Majseenko VI, Makarova AS, Maripov AM, Marusina AA, Melnikov ES, Moiseenko NB, Muradova FN, Muradyan RG, Myshak AO, Nikitina NM, Ogurlieva BB, Odegova AA, Omarova YM, Omurzakova NA, Ospanova SO, Pahomova EV, Petrov LD, Plastinina SS, Pogrebetskaya VA, Polyakov DS, Ponomarenko EV, Popova LL, Prokofeva NA, Pudova IA, Rakov NA, Rakhimov AN, Rozanova NA, Serikbolkyzy S, Simonov AA, Skachkova VV, Soloveva DV, Soloveva IA, Sokhova FM, Subbotin AK, Sukhomlinova IM, Sushilova AG, Tagayeva DR, Titojkina YV, Tikhonova EP, Tokmin DS, Tolmacheva AA, Torgunakova MS, Trenogina KV, Trostianetckaia NA, Trofimov DA, Tulichev AA, Tursunova AT, Ulanova ND, Fatenkov OV, Fedorishina OV, Fil TS, Fomina IY, Fominova IS, Frolova IA, Tsvinger SM, Tsoma VV, Cholponbaeva MB, Chudinovskikh TI, Shevchenko OA, Sheshina TV, Shishkina EA, Shishkov KY, Sherbakov SY, Yausheva EA, Musaelian SN, Belenkov YN, Arutyunov GP. Analysis of influence of background therapy for comorbidities in the period before infection on the risk of the lethal COVID outcome. Data from the international ACTIV SARS-CoV-2 registry (<<Analysis of chronic non-infectious diseases dynamics after COVID-19 infection in adult patients SARS-CoV-2>>). Kardiologiia. 2021 Sep 30;61(9):20-32. doi: 10.18087/cardio.2021.9.n1680. English, Russian.

    PubMed 34713782

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and SARS-CoV-2 Infection, run by Eurasian Association of Therapists at 1 site in Russia.

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 1 inclusion and 2 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 8 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 Russia. 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.

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?

rate of non-infectious diseases (time frame: 12 month since a moment of request of medical help). The study lists 5 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 NCT04492384, which also lists 3 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 8 Sep 2023.

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