Resources for Covid-19

Special populations

The infection with SARS-CoV-2 virus and the Covid-19 disease caused by the virus can be a serious health threat for special populations such as children and patients with cancer .

The first safe and effective treatments and vaccines are emerging. This page collects information on plans, ongoing trials and eventually results with Covid-19 treatments and SARS-CoV-2 vaccines for children and patients with cancer, by means of references to official or quality information on the internet.

Study plans

New medicines are required to be developed for children (see background in this blog). Here are the clinical trials with children and other studies to investigate medicines to treat or prevent (vaccines) Covid-19 in children (click on tab "Studies" to see details):

Authorised medicines

Medicines that were investigated and now have been authorised to treat or prevent (vaccines) Covid-19 by the European Medicines Agency (EMA) are listed on their webpage here, and such centrally authorised medicines are here:

Medical care resources

For children, and for adults and children with cancer, learned societies and other quality information providers make available recommendations, some of which are listed here, together with reviews and updates on Covid-19:

Vaccine trials and recommendations

Information about clinical trials (studies) has to be made public, and public registers can be queried in various ways . For vaccines evaluated by the European Medicines Agency (EMA) by 2020-12-23, the table below lists trials from a public register. Paediatric and adult patients with cancer may be excluded from a trial, for example if its protocol has exclusion criteria that refer to immunocompromised patients or patients with a serious condition. Added to the table is the information if such patients are excluded (columns immunosuppression_excluded, illness_excluded) from the respective trial, on the basis of a simple analysis of the eligibility criteria (click below to see the code of the analysis). Use the ctgov_link to check the full eligibility text and to verify the automated analysis here.

At the time of creating the table below, no trial with vaccines seemed to be specially designed to include patients with cancer, whether paediatric or adult. Such trials will be further tracked, to contribute to awareness of the availability of trials.

However, in their section "Who’s taken part in COVID-19 vaccine trials?", Cancer Research UK discuss some trials and how patients with cancer may have taken part so far, explaining the situation and the limited information that is available so far (https://scienceblog.cancerresearchuk.org/2020/12/15/covid-19-vaccine-and-cancer-latest-updates/).

Immunocompromised individuals are addressed in the section Special warnings and precautions for the Covid-19 Vaccine Comirnaty; do check the full wording here. The main trial for this vaccine included in total 81 patients with a leukaemia, lymphoma or metastatic solid tumour and in total 1395 patients with any malignancy, see comorbidities in the assessment report here. The discussion of the importance of favourable and unfavourable effects includes, "There are no efficacy data in immunocompromised individuals. Such patients may not be protected as well as immunocompetent individuals by vaccination. While there are limited safety data too in the immunocompromised subjects (a broad and disparate category), no particular safety issues are anticipated, and the benefit/risk balance of vaccination of such subjects is deemed positive, also in light of the underlying excess risk of COVID-19", in the assessment report here.

Recommendations by medical oncology societies have been started to be provided on the use of Covid-19 vaccines in immunosuppressed patients, in particular:

Created on 2021-02-10 18:30:09
intervention intervention name eligibility minimum age enrollment start date primary completion date immunosuppression excluded illness excluded ctgov link and identifiers
Ad26.COV2.S / Placebo 18 Years 1045 2020-07-15 2021-12-03 FALSE TRUE NCT04436276 CR108828, 2020-001483-28, VAC31518COV1001, NCT04436276
Ad26.COV2.S / Placebo 18 Years 44325 2020-09-07 2021-01-22 FALSE TRUE NCT04505722 CR108876, VAC31518COV3001, NCT04505722
Ad26.COV2.S / Placebo 20 Years 250 2020-08-11 2021-01-08 TRUE TRUE NCT04509947 CR108871, VAC31518COV1002, NCT04509947
Ad26.COV2.S / Placebo 18 Years 30000 2020-11-12 2022-05-10 FALSE TRUE NCT04614948 CR108916, 2020-003643-29, VAC31518COV3009, NCT04614948
AZD1222 18 Years 100 2020-09-02 2021-03-12 TRUE TRUE NCT04540393 D8111C00001, NCT04540393
AZD1222 / 0.9% (w/v) saline 18 Years 256 2020-08-23 2021-11-10 TRUE TRUE NCT04568031 D8111C00002, NCT04568031
AZD1222 / Placebo 18 Years 30000 2020-08-28 2021-03-23 TRUE FALSE NCT04516746 D8110C00001, NCT04516746
AZD1222 / rAd26-S 18 Years 100 2021-03-16 2021-11-16 TRUE TRUE NCT04684446 D8111C00003, NCT04684446
AZD1222 / rAd26-S 18 Years 100 2021-02-10 2021-04-09 TRUE TRUE NCT04686773 AZD1222 - rAd26-S, NCT04686773
Biological: mRNA-1273 / Placebo 18 Years 600 2020-05-29 2021-03-31 TRUE TRUE NCT04405076 mRNA-1273-P201, 75A50120C00034, NCT04405076
BNT162a1 / BNT162b1 / BNT162b2 / BNT162c2 18 Years 456 2020-04-23 2023-04-15 TRUE TRUE NCT04380701 BNT162-01, 2020-001038-36, U1111-1249-4220, NCT04380701
BNT162b1 / BNT162b2 / Placebo 12 Years 43998 2020-04-29 2021-08-03 TRUE TRUE NCT04368728 C4591001, 2020-002641-42, NCT04368728
BNT162b1 / Placebo 18 Years 144 2020-07-28 2020-09-30 TRUE TRUE NCT04523571 BNT162-03, NCT04523571
BNT162b2 18 Years 1280 2021-01-28 2021-04-09 TRUE TRUE NCT04713553 C4591017, NCT04713553
BNT162b2 / Placebo 20 Years 160 2020-10-21 2021-11-30 TRUE TRUE NCT04588480 C4591005, NCT04588480
BNT162b2 / Placebo 18 Years 960 2020-12-04 2021-12-15 TRUE TRUE NCT04649021 BNT162-06, NCT04649021
BNT162b3 18 Years 120 2020-09-09 2021-03-15 TRUE TRUE NCT04537949 BNT162-04, 2020-003267-26, U1111-1254-4840, NCT04537949
ChAdOx1 nCoV-19 (Abs 260) / MenACWY vaccine / ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost / Two dose MenACWY vaccine / ChAdOx1 nCoV-19 (qPCR) / ChAdOx1 nCoV-19 0.5mL prime plus boost / Two dose MenACWY vaccine min. 4 weeks apart / Two dose ChAdOx1 nCoV-19/Covishield 0.5mL / Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL 18 Years 12390 2020-05-28 2021-09-15 TRUE TRUE NCT04400838 COV002, NCT04400838
ChAdOx1 nCoV-19 / MenACWY / ChAdOx1 nCoV-19 full boost / ChAdOx1 nCoV-19 half boost / MenACWY boost / Paracetamol / ChAdOx1 nCoV-19 0.5mL boost 18 Years 1090 2020-04-23 2021-10-15 TRUE TRUE NCT04324606 COV001, NCT04324606
ChAdOx1 nCoV-19 / Normal saline 0.9% 18 Years 2130 2020-06-24 2020-12-15 TRUE TRUE NCT04444674 ChAdOx1 nCoV-19_ZA_phI/II v4.1, NCT04444674
ChAdOx1 nCoV-19 single dose + paracetamol / MenACWY single dose + paracetamol / ChAdOx1 nCoV-19 two dose + paracetamol / MenACWY prime & saline placebo boost + paracetamol 18 Years 10300 2020-06-02 2021-09-15 TRUE TRUE NCT04536051 COV003, NCT04536051
mRNA-1273 18 Years 120 2020-03-16 2021-11-22 TRUE TRUE NCT04283461 20-0003, 5UM1AI148684-02, NCT04283461
mRNA-1273 18 Years 180 2021-02-10 2021-07-01 TRUE FALSE NCT04748471 APHP201504, 2020-005889-34, NCT04748471
mRNA-1273 / Placebo 18 Years 30000 2020-07-27 2022-10-27 TRUE FALSE NCT04470427 mRNA-1273-P301, 75A50120C00034, NCT04470427
mRNA-1273 / Placebo 12 Years 3000 2020-12-09 2022-06-30 TRUE TRUE NCT04649151 mRNA-1273-P203, NCT04649151
Oral 13 cis retinoic acid / Aerosolized 13 cis retinoic acid / 13 cis retinoic acid doses orally in combination with spike protein based vaccine / Aerosolized 13 cis retinoic acid in combination with spike protein based vaccine / Biological: spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine 18 Years 360 2021-02-15 2021-04-15 TRUE TRUE NCT04730895 COVID vaccine, NCT04730895
SARS-CoV-2 rS - Phase 1 / SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 / Normal saline solution (NSS), Placebo - Phase 1 / Normal saline solution (NSS), Placebo - Phase 2 / SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1 / Normal saline solution (NSS), Placebo, Day 21 - Phase 1 / SARS-CoV-2 rS/Matrix-M Adjuvant, Days 0 and 21 - Phase 2 / Normal saline solution (NSS), Placebo, Day 189 - Phase 2 / SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 2 / Normal saline solution (NSS), Placebo, Day 21 - Phase 2 / SARS-CoV-2 rS/Matrix-M Adjuvant - Day 189 - Phase 2 18 Years 1419 2020-05-25 2020-12-01 TRUE TRUE NCT04368988 2019nCoV-101, NCT04368988
SARS-CoV-2 rS/Matrix M1-Adjuvant / Placebo / Licensed seasonal influenza vaccine 18 Years 15000 2020-09-28 2021-01-15 TRUE TRUE NCT04583995 2019nCoV-302, NCT04583995
SARS-CoV-2 rS/Matrix-M1 Adjuvant / Placebo 18 Years 4400 2020-08-17 2021-11-15 TRUE TRUE NCT04533399 2019nCoV-501, NCT04533399
SARS-CoV-2 rS/Matrix-M1 Adjuvant / Placebo 18 Years 30000 2020-12-27 2021-03-31 TRUE TRUE NCT04611802 2019nCoV-301, NCT04611802

References

Madhusoodhan, P. Pallavi, Joanna Pierro, Jordan Musante, Prachi Kothari, Bradley Gampel, Burton Appel, Adam Levy, et al. 2020. “Characterization of COVID-19 Disease in Pediatric Oncology Patients: The New York-New Jersey Regional Experience.” Pediatric Blood & Cancer, December, e28843. https://doi.org/10.1002/pbc.28843.
Jiang, Li, Kun Tang, Mike Levin, Omar Irfan, Shaun K. Morris, Karen Wilson, Jonathan D. Klein, and Zulfiqar A. Bhutta. 2020. “COVID-19 and Multisystem Inflammatory Syndrome in Children and Adolescents.” The Lancet. Infectious Diseases 20 (11): e276–88. https://doi.org/10.1016/S1473-3099(20)30651-4.
Herold, Ralf. 2018. Ctrdata: R Package to Aggregate and Analyse Information on Clinical Trials from Public Registers. https://github.com/rfhb/ctrdata.


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